S06_Solicitation Number 36C79126R0011_Amendment Number 0005_ETMPM-TENS Requirement_Conformed Copy_Issued_Dated 16OCT2026.pdf

36C79126R0011-0005

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER 3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

Offers must acknowledge receipt of this amendment prior to the hour, and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office. is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

1 1

0005 10-16-2026

VA-27-00004517

36C791

Department of Veterans Affairs Enterprise Procurement Office Acquisition Service Four Delta Team 555 Corporate Circle Golden CO 80401-5621 Contracting Officer: Maurice Walker E: maurice.walker@va.gov | P: 720-392-4318

36C791

Department of Veterans Affairs Enterprise Procurement Office Acquisition Service Four Delta Team 555 Corporate Circle Golden CO 80401-5621

To all Offerors:

See Section B.1.2.i of Solicitation

36C79126R0011

X

X X

No accounting or appropriations data are provided at the solicitation stage. The RFP does not obligate funds. The obligation of funds occurs at the Delivery Order level.

X 1

Amendment 0005 to Solicitation Number 36C79126R0011 revises and incorporates the following:

1. RFO Clause 52.225-1, Buy American Act – Supplies and the provision at RFO 52.225-2, Buy American Act Certificate and RFO Clause 52.225-5 Trade Agreements and the provision at RFO 52.225-6 Trade Agreement Certificate applicability to i i i this acquisition.

Maurice Walker Contracting Officer

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. OFFEROR CAGE CODE: FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:720-497-2304

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

VA-27-00004517

Acquisition Service Four Delta Team

36C79126R0011 09/18/2026

Contract Specialist: John Overstake P:720-497-2304 E: john.overstake@va.gov (720) 497-2304 10-30-2026

3PM CDT

36C791 Department of Veterans Affairs Enterprise Procurement Office Acquisition Services Four Delta Team 555 Corporate Circle Golden CO 80401-5621 Contracting Officer: Maurice Walker E: maurice.walker@va.gov | P: 720-392-4318

Y

334510

1250 Employees

Not Applicable

N/A

36C791

Department of Veterans Affairs Enterprise Procurement Office

555 Corporate Circle Golden CO 80401-5621

36C791

Department of Veterans Affairs Enterprise Procurement Office Acquisition Service Four Delta Team 555 Corporate Circle

All Offerors:

See Section B.1.2.i of Solicitation

Department of Veterans Affairs Denver Logistics Center Financial Div.

Attn: Mary (Darcy) Clodio (ORF)|E:dalc.invoices@va.gov 555 Corporate Circle

(303) 273-6231 (303) 215-9140

See CONTINUATION Page

This RFP constitutes a formal invitation for Offerors to submit proposals for the Electro Therapeutic Modalities for Pain Management & Transcutaneous Electrical Nerve Stimulation requirement. The purpose of this RFP is to competitively establish FFP single award IDIQ contracts for the procurement of the commercial devices identified at the CLINs and SLINs listed in Section B. Offerors shall propose to all CLINs/SLINs they wish to be considered for award, submit product samples for all proposed CLINs/SLINs, submit unit pricing on all proposed CLINs/SLINs, submit technical documentation, and evaluation tier appropriate end-product Country-Of-Origin certifications (TAA), and demonstrate full compliance with all universal Minimum Technical Requirements (MTRs) and CLIN/SLIN specific MTRs. Evaluation and award will be conducted on a per CLIN/SLIN basis in accordance with Tiered Set Aside Evaluation procedures and source selection methodologies described in Section E.

Offerors are strongly encouraged to carefully review all solicitation instructions and verify proposal completeness prior to the submission of a proposal.

$0.00 $0.00 See CONTINUATION Page

No accounting or appropriations data are provided at the solicitation stage. The RFP does not obligate funds. The obligation of funds occurs at the Delivery Order level.

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1.1 Acknowledgment of Solicitation Amendments:

1.2 Points of Contact (POCs):

1.3 Contracting Officer Authority and COR Designation:

1.4 Contract Modifications:

1.5 Scope of Contract and Change Orders Management:

B.2 STATEMENT OF NEED

B.3 BACKGROUND

3.1 INTRODUCTION & OBJECTIVES:

3.2 SCOPE:

3.3 CONTRACT PERIOD OF PERFORMANCE:

3.4 IDIQ TERMS AND CONDITIONS:

3.5 CONTRACT GUARANTEED MINIMUM AGGREGATE ORDER VALUE:

3.6 MINIMUM TECHNICAL REQUIREMENTS (MTRs):

3.7 CONTRACT ORDERING OFFICERS:

3.8 ORDERING PROCEDURES AND INFORMATION:

3.9 COMMUNICATION OF ORDERS:

3.10 COMMERCIAL PACKAGING:

3.11 COMMERCIAL WARRANTY:

3.12 DELIVERY AND SHIPPING REQUIREMENTS:

3.13 SHIPPING:

3.14 INSPECTION AND ACCEPTANCE:

3.15 PRODUCT REGULATORY COMPLIANCE:

3.16 PRODUCT MODIFICATION, REMOVAL OR RECALL:

3.17 NOTIFICATION OF SUBSTITUTED/ALTERNATIVE SUPPLY AND BACK-

ORDERED:

3.18 ANNUAL PRODUCT TECHNICAL REFRESH MECHANISM:

3.19 ELECTRONIC DATA INTERCHANGE (EDI) and ELECTRONIC INVOICING

REQUIREMENTS:

3.19.1 Introduction to Electronic Data Interchange:

3.19.2 Vendor EDI Exchange Requirements and ANSI X.12 Transaction Standards:

3.19.3 Electronic Invoicing (Tungsten):

3.19.4 Invoice Submission Requirements:

3.19.5 Customer Engagement Portal (CEP):

3.19.6 Quarterly Invoice Reports:

3.19.7 Invoice Issue Resolution:

3.20 VETERAN ENGAGEMENT AND INTERACTIONS:

3.20.1 Scope of Interaction:

3.20.2 Prohibited Activities:

3.20.3 Training and Compliance:

3.21 HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT

(HIPAA):

3.22 CONTRACTOR BUSINESS RELATIONSHIPS:

3.23 LIMITATIONS ON SUBCONTRACTING – MONITORING AND COMPLIANCE:

3.24 SUBCONTRACTING PLANS MONITORING AND COMPLIANCE:

3.25 GRAY MARKET PRODUCTS PREVENTION:

3.26 CONTRACT MODIFICATIONS:

3.27 QUALITY ASSURANCE AND SURVEILLANCE PLAN (QASP):

3.28 CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM

(CPARS):

3.28.1 CONTRACTOR PERFORMANCE METRICS:

3.28.1 PERFORMANCE REQUIREMENT SUMMARY TABLE:

SECTION C: CONTRACT CLAUSES

C.1 FAR CLAUSE 52.212-4, CONTRACT TERMS AND CONDITIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEVIATION OCT 2025)

C.3 FAR CLAUSE 52.216-18, ORDERING (AUG 2020)

C.4 FAR CLAUSE 52.216-19, ORDER LIMITATIONS (OCT 1995)

C.5 FAR CLAUSE 52.216-22, INDEFINITE QUANTITY (DEVIATION NOV 2025

C.6 FAR CLAUSE 52.217-9, OPTION TO EXTEND THE TERM OF THE CONTRACT

(MAR 2000)

C.7 FAR CLAUSE 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB1998)

C.8 VAAR CLAUSE 852.211-70 EQUIPMENT OPERATION AND MAINTENANCE

MANUALS (NOV 2018)

C.9 VAAR 52.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

SECTION D: ATTACHMENTS AND EXHIBITS

D.1 Attachment 0001 - Price Matrix D.2 Attachment 0003 - VAAR Clause 852.219-76, Limitations on Subcontracting Certificate of Compliance for Supplies and Products D.3 Attachment 0004 - FAR Provision 52.225-2, Buy American Certificate D.4 Attachment 0005 - FAR Provision 52.225-6, Trade Agreements Certificate

SECTION E: SOLICITATION PROVISIONS

E.1 FAR PROVISION 52.212-1, INSTRUCTIONS TO OFFERORS - COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (SEP 2023)(DEVIATION OCT 2025) ...52

E.2 ADDENDUM TO FAR PROVISION 52.212-1 INSTRUCTIONS TO OFFERORS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

E.3 RFO PROVISION 52.212-2, EVALUATION - COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (DEVIATION OCT 2025)

E.4 ADDENDUM to FAR PROVISION 52.212-2, EVALUATION - COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

E.5 FAR PROVISION 52.216-1 TYPE OF CONTRACT (APR 1984)

E.6 RFO PROVISION 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY

REFERENCE (FEB 1998)

E.7 RFO PROVISION 52.252-5 AUTHORIZED DEVIATIONS IN PROVISIONS (NOV

2020)

E.8 VAAR PROVISION 852.252-1 SOLICITATION PROVISIONS INCORPORATED BY

REFERENCE (FEB 1998)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1.1 Acknowledgment of Solicitation Amendments:

The Offerors to this solicitation hereby acknowledges receipt of the following amendments to this solicitation enumerated and dated as follows (If applicable):

AMENDMENT NUMBER DATE ISSUED

0001 9/30/2026 0002 10/02/2026 0003 10/06/2026 0004 10/15/2026 0005 10/16/2026

1.2 Points of Contact (POCs):

The Points of Contact (POCs) identified in this section constitute the only authorized representatives of the Government and the Offeror for all matters relating to contract administration. These individuals are the legally recognized parties to the agreement and serve as the exclusive channels through which official communications, contractual actions, and administrative coordination will occur. For the Government, the designated POC is the Contracting Officer (CO), who holds sole authority to bind the United States, issue contractual directions, interpret the terms and conditions of the solicitation and resultant contract, and execute contract modifications in accordance with Revolutionary Federal Acquisition Regulation (RFO/FAR) and Veterans Administration Acquisition Regulation (VAAR) requirements.

Secondary Government points of contact, such as Contract Specialists (CS), may support administrative functions; however, they do not possess authority to alter the contract or commit the Government in any manner. For the Offeror, the designated POC must be a duly authorized company official authorized to legally bind the entity to the Government. This individual must possess the corporate authority to sign and certify proposals, accept and execute contract awards, and enter into contract modifications. The Offeror shall ensure this representative is clearly identified on the Standard Form (SF) 1449 in the “YELLOW” highlighted fields of Section B.1.2(i) and must provide complete contact information including legal business name, business address, primary POC name, telephone number, and email address. This designated POC will be the sole recipient of all official correspondence from the Government and the individual responsible for all contractual engagements throughout the life of the contract. By completing the required fields, the Offeror affirms that the individual identified possesses full legal authority to act on behalf of the company for all binding contractual purposes. No other employee, representative, or affiliate of the Offeror is authorized to negotiate, modify, or engage in contract actions unless formally delegated in writing by the company and acknowledged by the Contracting Officer. This requirement ensures clear lines of communication, prevents unauthorized commitments, preserves the integrity of the contractual relationship, and maintains compliance with all applicable procurement statutes, regulations, and VA acquisition policy.

i. OFFEROR / CONTRACTOR:

Legal Business Name: ______________________________________________

Business Address: _________________________________________________

POC’s Name: _____________________________________________________

Phone Number: ___________________________________________________

E-mail Address: ___________________________________________________

b. GOVERNMENT:

Agency: Department of Veterans Affairs (VA), Enterprise Procurement Office (EPO) - AS4 Delta Team.

Address: 555 Corporate Circle, Golden, CO 80401-5621.

Primary POC Name: Maurice Walker (Contracting Officer) Primary POC Phone Number: (720) 392-4318 Primary POC E-mail Address: maurice.walker@va.gov

Secondary POC Name: John Overstake (Contract Specialist) Secondary POC Phone Number: (720) 497-2304 Secondary POC E-mail Address: john.overstake@va.gov

1.3 Contracting Officer Authority and COR Designation:

The EPO AS4D CO is responsible for providing overall scope of contract oversight, maintaining effective communications between the performing Contractors and the United States Department of Veterans Affairs (VA), ensuring strict contract compliance, administering contracts and contract modifications, and ensuring that annual Contractor Performance Assessment Reporting System (CPARS) performance evaluations are completed at the base Indefinite Delivery Indefinite Quantity (IDIQ) contract level. Any CO assigned to the EPO and acting with his/her warrant authority may take formal action on this contract when a contract action needs to be taken and the primary CO is unavailable. The CO reserves the right to designate a Contracting Officer’s Representative (COR) at the base IDIQ contract level. The CO must issue a COR designation letter to the assigned individual and provide a copy to the Contractor to ensure that all parties understand the limited authority of the COR. The CO must issue Denver Logistic Service (DLS) Ordering Officer (OOs) Authorization Letters to the assigned designees who are granted authority to process delivery orders under this contract.

Only EPO CO’s and designated OOs may order products under this contract.

1.4 Contract Modifications:

The resultant contracts awarded against this solicitation will be Firm-Fixed Price (FFP) IDIQ type contracts, and the terms and conditions of these contracts may only be changed by a written contract modification executed by an EPO AS4D warranted CO.

The resultant performing Contractors must not provide products or services not expressly stated within the awarded FFP/IDIQ contracts. The EPO AS4D CO is the only Government official authorized to modify the resultant contracts to be awarded against this solicitation.

1.5 Scope of Contract and Change Orders Management:

Offerors are hereby advised of the potential for post-award change orders to the resultant contracts to be awarded against this solicitation, which must be incorporated by the execution of bilateral contract modifications when the CO determines in writing that the change order is within the scope of the original IDIQ base contract.

B.2 STATEMENT OF NEED

The Department of Veterans Affairs (VA), Veterans Health Administration (VHA), requires a national, enterprise-wide follow-on procurement and ordering vehicle to ensure the uninterrupted availability of Food and Drug Administration (FDA)-cleared Electro-Therapeutic Modalities for Pain Management (ETMPM) and Transcutaneous Electrical Nerve Stimulation (TENS) devices and accessories.

a. This requirement replaces the expiring legacy IDIQ contract 36C79122D0005 (e.g., expiration date of January 19, 2027) and supports critical non-opioid based pain-management programs across 168 VA Medical Centers, 1,053 Community Based outpatient Clinics (CBOCs), and additional VHA healthcare facilities.

b. This current acquisition effort consolidates and expands the existing legacy TENS procurement program to include Interferential Current Therapy (IFC) devices, short-wave diathermy (SWD) devices (both thermal and non-thermal devices), portable neuromodulation systems for the treatment of headache disorders, electrodes, lead wires, chargers, garment-based applicators, and associated consumables and accessories. Each product included in this requirement is mapped to unique parent Contract Line Item Numbers (CLINs) and discrete subordinate Sub-Line Item Numbers (SLINs) with individualized Minimum Technical Requirements (MTRs) enumerated at the CLIN/SLIN level.

c. VHA’s National Prosthetic and Sensory Aids Service (PSAS) requires continuous access to standardized, durable, FDA-cleared electrotherapeutic devices supporting non-opioid pain-management treatment plans. Demand for ETMPM-TENS devices is nationwide and growing year-over-year, the need is recurring, subject to high-volume ordering, and clinically essential to the VA. The requirement directly supports the VA’s mission to deliver safe, effective, non-pharmacological pain-management solutions to millions of Veterans. The VHA’s PSAS has a bonafide need for the establishment of a VA enterprise-wide ETMPM-TENS product procurement and IDIQ ordering vehicle to ensure:

i. Standardized ETMPM-TENS product quality and clinical consistency;

ii. Streamlined product ordering via the VA’s Remote Order Entry System

(ROES);

iii. Efficient supply-chain management through the VA’s Denver Logistics Services (DLS);

iv. Predictable ETMPM-TENS product unit pricing throughout the ordering period;

v. Sustained and stable long-term successful contract performance delivered by responsible Vendors; and

vi. Protection against ETMPM-TENS product shortages, DLS stock outages, and product supply interruptions.

B.3 BACKGROUND

The Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Prosthetic and Sensory Aids Service (PSAS), has determined a continuing enterprise-wide need for FDA-cleared Electro-Therapeutic Modalities for Pain Management (ETMPM) and Transcutaneous Electrical Nerve Stimulation (TENS) devices and associated accessories.

These products directly support VHA’s national non-opioid pain-management programs and are essential for delivery of safe, standardized, and clinically effective therapeutic care across 168 VA Medical Centers and over 1,000 Community Based Outpatient Clinics (CBOCs).

a. This procurement effort follows the expiring national TENS IDIQ contract number 36C79122D0005, which is scheduled to end on January 19, 2027, and expands the scope of the legacy TENS requirement by incorporating additional ETMPM device categories such as Interferential Current (IFC) units, Short-Wave Diathermy (thermal and non-thermal) systems, neuromodulation devices, and clinically essential consumable supplies (electrodes, leads, gels, and related accessories).

b. VHA market research performed from January through July 2026 confirmed that the commercial marketplace for ETMPM-TENS products is mature, stable, and fully capable of supporting the VA’s nationwide demand. All required device categories are commercially available items manufactured predominantly by a small number of large Original Equipment Manufacturers (OEMs) and distributed through nationwide networks of authorized Durable Medical Equipment (DME) suppliers or distributors. The commercial market shows broad availability, predictable pricing, and no indicators of supply-chain instability, raw-material shortages, or elevated performance risks during the anticipated period of performance.

c. The VA Denver Logistics Service (DLS), operating as the Denver Logistics Center

(DLC), serves as the Government’s centralized receiving, stocking, and distribution facility for ETMPM-TENS products. Under the legacy TENS contract, historical performance demonstrated that authorized distributors reliably delivered ordered products within established 30-day delivery requirements, maintained uninterrupted supply support, and ensured clinical continuity for Veteran patients.

d. The ETMPM-TENS recompete requirement is therefore structured to ensure continued enterprise-wide availability of clinically essential products, alignment with ROES-based ordering workflows, and preservation of standardized product quality at fixed unit prices over the five-year ordering period. This procurement is designated as a national follow-on requirement, not a bundled or consolidated acquisition.

e. Market research identified no mandatory Government sources, Federal excess property, or AbilityOne products capable of meeting the CLIN/SLIN-level Minimum Technical Requirements (MTRs). No Organizational Conflicts of Interest were identified.

f. The acquisition will use multiple single-award Base IDIQ contracts and resultant

FFP/IDIQ Delivery Order contract vehicles awarded at the CLIN/SLIN level to ensure pricing competitiveness, broaden supplier participation, and sustain VA enterprise-wide supply-chain reliability.

g. The results of market research also confirmed the relevance of the principal NAICS 334510 (Electromedical and Electrotherapeutic Apparatus Manufacturing), PSC 6515 (Medical and Surgical Instruments, Equipment, and Supplies), and the continuing applicability of FDA 510(k) clearance, Buy American Act (BAA) is not applicable to this acquisition, Trade Agreements Act (TAA) applicability to this acquisition, and VA-specific prohibitions relating to refurbished products, gray-market products, or other non-authorized products are strictly prohibited in this procurement. These conditions, combined with demonstrated increases year-over-year enterprise-wide demand for ETMPM-TENS products and the absence of VA inventory capable of meeting specifications, establish a clear and well-supported Government requirement for this recompete procurement effort.

h. Accordingly, the VA is issuing this solicitation to establish national ETMPM-TENS contract vehicles that ensure uninterrupted patient care, predictable unit pricing, streamlined enterprise ordering, and sustained delivery of FDA-cleared ETMPM-TENS devices and accessories essential to VHA’s mission of delivering safe, effective, non-pharmacological pain-management treatments to Veterans nationwide.

3.1 INTRODUCTION & OBJECTIVES:

The Department of Veterans Affairs (VA) Enterprise Procurement Office (EPO) and the Denver Logistics Service (DLS), known and operating as Denver Logistics Center (DLC) manage holistic supply chain management for the VA National Audiology, Prosthetics, and Telehealth Programs and supports VA and other Government agencies with professional acquisition and logistical services. The Department of Veterans Health Administration (VHA) Prosthetic and Sensory Aids Service (PSAS) has identified the need to procure Electro-Therapeutic Modalities for Pain Management devices and supplies through EPO and the DLC in order to meet Veteran Patient care needs and align to the MISSION Act to meet the needs of the Veteran. VHA has made a considerable investment organizationally as well as in medical technologies to support advancing health technology and capabilities. The Department of Veterans Health Administration (VHA) National Prosthetic and Sensory Aids Program Office (PSAS) has identified Electro-Therapeutic Modalities for Pain Management devices and supplies as preferred products for consolidated contracting through the Department of Veterans Affairs (VA), Enterprise Procurement Office (EPO), and the Denver Logistics Center (DLC). The objectives are to:

a. Improve the quality of health for the Veteran;

b. Increase the quality of health care available throughout VHA;

c. Improve the efficiency of health care providers and staff;

d. Increase Veterans’ overall satisfaction with VA/VHA;

e. Obtain quality products at lower than current open-market prices and prices advantageous to the scale of VA procurements for the Veteran patient population;

f. Ensure availability and consistency of product for nationwide usage while integrating the DLC ROES program for ordering. Products will be ordered using the DLC’s Remote Order Entry System (ROES) and will be shipped from the DLC directly to the clinic or in some cases the Veteran. This mechanism will be the primary source for contracted products for the VA;

g. Improve operating efficiency throughout the VA; and

h. This contract will also allow for higher level of effective communication between the

Government and Contractor, which is essential for partnering for this performance-based contract to succeed. The success of this Contract is shared between the Government and the Contractor.

3.2 SCOPE:

VA’s purpose under this solicitation and resulting contract is to obtain Electro-Therapeutic Modalities for Pain Management devices and supplies while securing a continuous supply of products. These products are purchased by the VA EPO and DLC for stocking, distribution, and assignment to individual VA medical facilities and subsequent issue to Veteran patients. This provides the Contractor with a single point of contact for all ordering activity under the contract.

All orders will be placed by the CO and duly appointed Ordering Officers to replenish depleted stock. The VA has been providing Electro-Therapeutic Modalities for Pain Management devices and supplies to eligible Veterans for multiple years. The need for Electro-Therapeutic Modalities for Pain Management devices and supplies for Veterans has increased steadily over the years. To meet the increasing demand with the highest level of technology at the lowest prices, VHA National Prosthetic and Sensory Aids (PSAS) has worked in conjunction with DLC and EPO to develop contracts for Electro-Therapeutic Modalities Pain Management devices and supplies that provide the best value. The Department of Veterans Affairs intends to solicit and award a multiple award Indefinite Delivery Indefinite Quantity contract(s) to provide the widest range of technologies for clinicians and Veterans and to ensure that the demand created by the large volume of pain management device prescriptions generated by the VA can be met. The preferred product features shall be defined by clinical prescription which profile the intended user and environment as well as physical/performance specifications. The contract will fulfill the supply requirement for the Electro-Therapeutic Modalities for Pain Management devices and supplies nationwide throughout the VA. The Contractor(s) shall provide an uninterrupted source of supply of various Electro-Therapeutic Modalities for Pain Management devices and supplies that meet or exceed the specifications and deliver within the terms of the contract(s).

Delivery shall take place within 30 calendar days of the ROES delivery order issuance. The delivery orders placed through ROES shall indicate the specific items ordered, item quantities, and all necessary delivery and payment procedures. Implementation of the contracts will be accomplished by the DLC and EPO under the purview of VHA National Prosthetics and Sensory Aids Program Office (PSAS).

3.3 CONTRACT PERIOD OF PERFORMANCE:

Base Year January 20, 2027, through January 19, 2028 Option Year One January 20, 2028, through January 19, 2029 Option Year Two January 20, 2029, through January 19, 2030 Option Year Three January 20, 2030, through January 19, 2031 Option Year Four January 20, 2031, through January 19, 2032

3.4 IDIQ TERMS AND CONDITIONS:

Supply chain management issues are handled by the Denver Logistics Center (DLC). The DLC is paramount in the ordering, receiving, and supply distribution process. The DLC will issue ROES delivery orders to the Contractor which shall indicate the specific item(s) ordered, the quantities of the item(s) ordered, and all necessary delivery and invoicing procedures.

3.5 CONTRACT GUARANTEED MINIMUM AGGREGATE ORDER VALUE:

In accordance with RFO 16.504(a)(d), RFO 16.505(a), and VA acquisition policy, the VA intends to make multiple single-awards of between one (1) and five (5) separate Base IDIQ contracts, each immediately followed by issuance of the corresponding funded FFP/IDIQ Delivery Order at time of award. Awards are made per CLIN/SLIN, and any responsible Offeror may be awarded more than one (1) CLIN/SLINs, resulting in one (1) to five (5) total Base IDIQ contract and resultant FFP/IDIQ Delivery Order awards depending on the outcomes of the competition. Because each CLIN/SLINs is awarded as a single-award IDIQ, there is no further competition at the Delivery Order level under FAR 16.505(b)(2)(i).

a. Consistent with RFO 16.504-1(a), each awarded Base IDIQ contract and resultant FFP/IDIQ Delivery Order shall include its own distinct minimum guaranteed order amount of $5,000.00, which is obligated one time within the Base Year period of performance if required. However, consistent with RFO 16.504-1(a)-(d), the requirement to establish a reasonable maximum quantity/value based on documented program needs, the VA will not assign five

(5) independent ceilings of $500M each. Instead, the VA is establishing a single unified maximum aggregate order value (“contract maximum”) of $500,000,000.00 for the entire ETMPM-TENS procurement program, inclusive of all awards made under this solicitation.

b. This $500,000,000.00 aggregate ceiling represents the total maximum ordering authority for all resultant Base IDIQ contracts and resultant FFP/IDIQ Delivery Orders combined across all five (5) years, if all options are exercised. This aggregate ceiling amount is supported by program demand analysis, historical usage, market research, and VAAM acquisition planning policy. Per RFO 16.504- 1(d), the VA will proportion and assign appropriate maximum ordering values to each awarded Base IDIQ contract and resultant FFP/IDIQ Delivery Order at the time of award, ensuring that the sum of all individual contract maximums does not exceed the aggregate program ceiling of $500,000,000.00. Accordingly:

i. Each Base IDIQ contract has its own separate $5,000.00 minimum guarantee, obligated once at contract award, in accordance with RFO 16.504-1(a).

ii. The maximum aggregate order value for the entire procurement is $500,000,000.00, representing the total combined ceiling for all awarded Base IDIQ contracts across all CLINs/SLINs.

iii. Individual contract maximums will be proportioned from within the $500,000,000.00 aggregate ceiling at the time of award, consistent with RFO 16.504-1(a) and VAAM acquisition planning requirements; the ceilings do not multiply by the number of awardees.

iv. The aggregate ceiling applies program-wide, and total cumulative obligations across all Delivery Orders under all awarded Base IDIQ contracts may not exceed $500,000,000.00 during the five-year ordering period, if all options are exercised.

v. This structure aligns with RFO Subpart 16.5, VAAR, and VAAM requirements for establishing defensible IDIQ minima and maxima and ensures proper ceiling control, fiscal accountability, and compliance with ordering limitations under RFO 16.506.

3.6 MINIMUM TECHNICAL REQUIREMENTS (MTRs):

The Recompete of the ETMPM-TENS Procurement Program establishes a unified, enterprise-wide framework to ensure the VA acquires safe, FDA-cleared, clinically effective electro-therapeutic devices and accessories for nationwide Veteran pain-management care.

Central to this framework are the Universal Minimum Technical Requirements (MTRs) and the structured use of Contract Line Item Numbers (CLINs) and Sub-Line Item Numbers (SLINs).

The Universal MTRs apply to every therapeutic device (CLIN) offered under the program. These requirements mandate that all devices be Original Equipment Manufacturer (OEM) -new, Food and Drug Administration (FDA) 510(k) cleared for home use, fully operational out-of-the-box with included accessories, independent of subscription models or smart-device applications, properly labeled and serialized for logistics tracking, supported by English-language instructions and browser-based patient-training resources, and covered by a one-year warranty with full-replacement protections. These standards ensure clinical reliability, patient safety, regulatory compliance, and supply-chain consistency across all VA medical centers and outpatient facilities. To organize and manage this complex national equipment portfolio, the program utilizes a hierarchical product structure consisting of CLINs and SLINs. CLINs represent the therapeutic devices themselves such as TENS units, IFC devices, Shortwave Diathermy systems, and neuromodulation devices. Each CLIN captures the core technical requirements, performance parameters, and safety features of a specific electro-therapeutic modality. SLINs represent the corresponding accessories required for full device operation such as electrodes, lead wires, chargers, or modality-specific components. SLINs inherit universal MTR expectations while adding accessory-specific salient characteristics such as dimensions, materials, packaging quantities, and compatibility requirements. Together, the universal MTRs and the CLIN/SLIN structure provide a standardized, regulatory-compliant, clinically driven, and logistically robust acquisition model. This structure ensures that all electro-therapeutic devices and accessories procured under the recompete of the ETMPM-TENS procurement program are technically acceptable, interoperable, traceable, and ready for immediate clinical use supporting uninterrupted, safe, and effective pain-management therapy for Veterans across the VA healthcare enterprise.

a. MTRs: The MTRs establish the baseline technical, safety, usability, regulatory, and packaging standards required of every device/unit offered under the recompete ETMPM- TENS procurement program.

These requirements apply to all Contract Line Item Numbers (CLINs), which represent the fully assembled, FDA cleared therapeutic devices themselves. Device accessories, identified under Sub Line Item Numbers (SLINs), have their own separate accessory specific MTRs. Together, the CLIN and SLIN structure supported by the following universal MTRs ensures that every ETMPM TENS device and accessory supplied to the Department of Veterans Affairs (VA) is FDA cleared, clinically appropriate, fully operational out of the box, safe, durable, standardized across the VA enterprise, warranty protected, and traceable through serial and bar code labeling. This structure provides the VA with consistent national supply chain reliability, clear product accountability, and robust technical compliance for all devices and accessories procured under the recompete ETMPM-TENS procurement program.

b. CLINs: CLINs represent the primary therapeutic devices being procured, such as TENS units, IFC devices, Shortwave Diathermy devices (e.g., thermal and non‑thermal), and portable neuromodulation devices. Each CLIN corresponds to a distinct medical device with its own required performance parameters and technical characteristics.

CLINs are individually priced, technically evaluated, and serve as the basis for warranty, regulatory compliance, and product performance requirements.

i. CLIN Naming Convention: The program employs clearly defined naming conventions to ensure traceability and administrative clarity as follows

a) CLINs use a four‑digit alphanumeric identifier (e.g., X001, X002).

b) The first character of the CLIN indicates the period of performance:

c) “0” = Base Year;

d) “1–4” = Option Years One (1) through Four (4); and

e) “X” = Pre‑award or solicitation‑phase CLIN identification applicable across all periods of performance until the time of award.

f) The last three digits uniquely identify the device type.

c. SLINs: SLINs represent the accessories, components, and consumables associated with each device, such as electrodes, lead wires, chargers, and other device‑specific accessories. SLINs may be informational only (e.g., tracking of product categories only) or priced (e.g., separately priced products for ordering of specific accessory items).

SLINs inherit the universal MTRs applicable to the associated CLIN but also contain additional accessory‑specific salient characteristics for example, electrode dimensions, material requirements, gel properties, quantities per package, or skin‑sensitivity variants.

i. SLIN Naming Convention:

a) SLINs extend the CLIN with two (2) additional alphanumeric characters

(e.g., X001AA, X001AB).

b) Alphabetic SLINs (AA–ZZ, excluding I and O) are used for priced deliverables, such as the accessories associated with the CLIN.

c) Numeric SLINs (01–99) are used for informational tracking purposes only, administrative purposes, or unpriced product categories.

d) SLINs are always subordinate to their parent CLIN and cannot exist independently.

d. CLINs and SLINs Mapping:

i. CLIN X001 - Portable TENS Device;

ii. SLIN X001AA - TENS Electrodes (2 in.);

iii. SLIN X001AB - TENS Electrodes (2 in. x 4 in.);

iv. SLIN X001AC - TENS Electrodes (2 in. & 2 in. x 4 in., Sensitive Skin);

v. SLIN X001AD - TENS Electrodes (Offeror Proposed Alternate Options);

vi. CLIN X002 - Portable Interferential Current (IFC) Device;

vii. SLIN X002AA - IFC Electrodes (2 in.);

viii. SLIN X002AB - IFC Electrodes (2 in. x 4 in.);

ix. SLIN X002AC - IFC Electrodes (2 in. & 2 in. x 4 in., Sensitive Skin);

x. SLIN X002AD - IFC Electrodes (Offeror Proposed Alternate Options);

xi. CLIN X003 - Shortwave Diathermy Device (Thermal);

xii. CLIN X004 - Shortwave Diathermy Device (Non-thermal);

xiii. CLIN X005 - Portable Neuromodulation Device - For Headache Disorders;

and

xiv. SLIN X005AA - Neuromodulation Electrodes (Offeror Proposed Alternate Options).

e. Universal MTRs: The universal MTRs establish the foundational technical, safety, regulatory, usability, and packaging standards that every electro-therapeutic device offered under the recompete ETMPM-TENS procurement program must meet.

These universal MTRs apply to all CLINs, ensuring that every device regardless of its therapeutic modality meets consistent enterprise-wide expectations for FDA compliance, operational readiness, patient usability, product durability, warranty protection, and logistical traceability. By defining these standards at the CLIN (device) level, the Government ensures the delivery of safe, clinically reliable, fully functional, and non-refurbished medical devices that support nationwide Veteran pain-management treatment. These requirements form the baseline against which all offered devices are evaluated for technical acceptability, and they work in tandem with accessory-specific MTRs established under their corresponding SLINs.

Together, the universal MTRs guarantee that every product introduced into the VA supply chain is fully compliant, traceable, operational out-of-the-box, and suitable for high-volume, enterprise-level clinical use across all periods of performance under this procurement program. The universal MTRs are as follows:

i. Device must have FDA 510(k) clearance for home-use indications (or other applicable FDA authorization).

ii. Device must be new and not refurbished.

iii. Device must not require a subscription service or renewal of subscription service to function.

iv. Operation and function of the device must be independent of a smart device application.

v. Device must include a Product Instruction Manual written in the English language.

vi. The manufacturer must provide a web-based, patient-facing training accessible to the general public through a browser, not including social media sites as the delivery mechanism.

vii. Device must have a visible serial number.

viii. Device packaging must have a visible serial number and bar code.

ix. Device must include a storage pouch or case large enough to store the device and the device’s accessories.

x. Device must have a one (1) year warranty from the date of delivery.

f. CLIN X001 - PORTABLE TENS UNIT MTRs:

i. Device must be capable of multiple uses/treatments per day without limits.

ii. Device must have a digital display feature indicating battery level, intensity level, and duration time.

iii. Device must have Dual Independent Channel Output.

iv. Device shall use a Biphasic waveform.

v. Device must have a minimum of two modes: a continuous and a timer feature for programmed duration of treatment.

vi. Device must have Adjustable Pulse Width and Frequency.

vii. Device must include a visual display with back lighting, visual display shall have adequate readability in typical clinical/home lighting conditions (e.g., backlighting or equivalent illumination and readability).

viii. Device shall include a minimum of two (2) sets of connecting lead wires, with two (2) lead wires per set (total quantity of four (4) connecting lead wires), supplied in the device package.

ix. Device shall include, at minimum, a package containing four (4) self-adhesive, reusable electrodes of nominal size 2 in × 2 in (square/rectangular or 2 inches across the widest point for oval pads).

x. Device must include Rechargeable Batteries.

xi. Device must include a Battery Charger.

xii. Device must include a belt clip.

g. SLIN X001AA - TENS ELECTRODES 2 in. x 2 in. MTRs:

i. Electrode pads must be:

a) A nominal size of 2 inches (square: 2 in × 2 in; circular: 2 in maximum diameter);

b) Manufactured from flexible non-porous material;

c) Electrode pads shall utilize reusable adhesive gel suitable for multiple applications, and the adhesive gel shall be included as part of the packaged electrode set;

d) Latex free; and

e) Provided in a package of a minimum of four (4) electrodes.

h. SLIN X001AB - TENS ELECTRODES 2 in. X 4 in. MTRs:

a) A nominal size 2 in. × 4 in. (rectangular) or 4 in. across the widest point (oval);

quantity of four (4) each;

i. SLIN X001AC - TENS ELECTRODES SENSITIVE SKIN MTRs: Alternative electrode pads must be available for users who experience skin sensitivity:

a) A nominal size 2 in. × 2 in. (square or 2 in. across the widest point -circular); quantity of four (4) each;

e) Electrode pads shall be supplied in a package containing a minimum of four (4) electrodes total, consisting of: four (4) pads of nominal size 2 in. × 2 in. (square or 2 in. across the widest point for circular pads).

j. SLIN X001AD - TENS ELECTRODES ALTERNATE OPTIONS MTRs: Offerors may list all sizes, shapes of garments, pads that are offered as additional options for the device for the VA to consider.

i. All offerings must be:

a) Flexible non-porous material;

b) Electrode pads shall utilize reusable adhesive gel suitable for multiple

c) Latex free; and

d) Provided in a package of a minimum of four (4) electrodes.

j. CLIN X002 - PORTABLE INTERFERENTIAL CURRENT (IFC) UNIT MTRs:

i. Device must be capable of multiple uses/treatments per day without limits.

ii. Device must have a digital display feature indicating battery level, intensity level, duration time.

iii. Device must have single and dual channel capability.

iv. Device must use a carrier wave of medium frequency.

v. Device must have adjustable treatment frequencies (Hz).

vi. Device must have multiple modes.

vii. Device must have a timer feature for programed duration of treatment.

viii. Device must have adjustable treatment intensity.

ix. Device must include a visual display with back lighting, visual display shall backlighting or equivalent illumination and readability).

x. Device shall include a minimum of two (2) sets of connecting lead wires, with two (2) lead wires per set (total quantity of four (4) connecting lead wires), supplied in the device package.

xi. Device shall include, at minimum, a package containing four (4) self-adhesive, reusable electrodes of nominal size 2 in × 2 in (square or 2 inches across the widest point for oval pads).

xii. Device must be rechargeable.

xiii. Device must include a charging apparatus and include all power cords with

120-volt power adapter.

k. SLIN X002AA IFC ELECTRODES 2 in. x 2 in. MTRs:

a) A nominal size of 2 inches (square: 2 in × 2 in; circular: 2 in maximum diameter);

l. SLIN X002AB - IFC ELECTRODES 2 in. x 4 in. MTRs:

a) A nominal size 2 in. × 4 in. (rectangular) or 4 in. across the widest point (oval);

quantity of four (4) each;

m. SLIN X002AC - IFC ELECTRODES SENSITIVE SKIN MTRs: Alternative electrode pads must be available for users who experience skin sensitivity:

a) A nominal size 2 in. × 2 in. (square or 2 in. across the widest point -circular); quantity of four (4) each;

b) Flexible non-porous material;

c) Reusable adhesive gel to allow for multiple use;

e) Electrode pads shall be supplied in a package containing a minimum of four (4) electrodes total, consisting of: four (4) pads of nominal size 2 in. × 2 in. (square or 2 in. across the widest point for circular pads).

n. SLIN X002AD - IFC ELECTRODES ALTERNATE OPTIONS MTRs: Offerors may list all sizes, shapes of garments, pads that are offered as additional options for the device for the VA to consider.

ii. All offerings must be:

a) Flexible non-porous material;

o. CLIN X003 - SHORT WAVE DIATHERMY THERMAL UNIT MTRs:

i. Device must be capable of multiple uses/treatments per day without limits;

ii. Device usage must not be limited to a pre-established volume or timeline unless this limit is related to manufacturer safety guidelines or FDA clearance;

iii. Device must have a digital display feature indicating battery level, duration time as applicable to the device;

iv. Device must include a visual display with back lighting, visual display shall backlighting or equivalent illumination and readability);

v. Device must list all modes available;

vi. Device must be rechargeable; and

vii. Device must include a charging apparatus and include all power cords with

p. CLIN X004 - SHORT WAVE DIATHERMY NON-THERMAL MTRs:

i. Device must be capable of multiple uses/treatments per day without limits;

iii. Device must have a digital display feature indicating battery level, duration time as applicable to the device;

iv. Device must include a visual display with back lighting, visual display shall backlighting or equivalent illumination and readability);

v. Device must list all modes available;

vi. Device must be rechargeable; and

q. CLIN X005 - PORTABLE NEUROMODULATION DEVICE FOR HEADACHE

DISORDERS MTRs:

i. Device must be capable of multiple uses per day, shall not be a single or limited use device;

iii. Device must have a digital display feature indicating battery level, intensity level, and duration time as applicable to the device;

iv. Device must list all modes available;

v. For devices that require conductive gel or spray must be included with the device;

vi. Device must be rechargeable;

120-volt power adapter; and

viii. For devices with electrodes, the following criteria must be met:

ix. Device must include at a minimum a package of four (4) self-adhesive, reusable electrodes; and

x. Alternative…