6515--DUOLITH Acute Care Shockwave Therapy Device - 518-26-4-7480-0062

Combined Synopsis Solicitation for Commercial Products and Commercial Services

DuoLith SD1 T TOP Ultra Dual Modality Shockwave Therapy System & OrthoPulse Ultra 100

This is a combined synopsis/solicitation for commercial products prepared in accordance with Revolutionary FAR Overhaul (RFO) in FAR 12.202, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through the most recent Federal Acquisition Circular (FAC).

Set Aside: UNRESTRICTED (Open Market)

NAICS: 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing

PSC/FSC: 6515 Medical and Surgical Instruments, Equipment, and Supplies

Small Business Size Standard: 1,250 employees

Procuring Activity

Department of Veterans Affairs

Network Contracting Office 1 (New England)

940 Belmont Street, Brockton, MA 02301

Point of Contact: Harris, Sherrye Sherrye.Harris@va.gov

Delivery Terms and Address

FOB: Destination

Delivery Address: VAMC Bedford, 200 Springs Road, Bedford, MA 01730

Required Delivery Date: Vendor to state best achievable lead time.

Supplies/Services

Line Item 0001 DuoLith SD1 T TOP Ultra Dual Modality Shockwave Therapy System

Quantity: 1 Each

Description: Dual modality shockwave therapy system on a single platform/cart providing both focused (electromagnetic, FSW) and radial/pressure wave (RPW) delivery; configured for shared clinical use by Pain and Podiatry.

Salient Characteristics:

Dual modality shockwave on a single platform/cart: BOTH focused (electromagnetic, FSW) and radial/pressure wave (RPW) delivery. Pain and Podiatry use both modalities for different tissue depths and indications; a single modality device would not meet the shared clinical need.

Focused source with FDA labeling supporting the chronic plantar fasciitis indication for Podiatry s use (PMA/approval for chronic proximal plantar fasciitis).

Focused source parameters: energy flux density approximately 0.01 to 0.55 mJ/mm²; adjustable focal depth via stand offs with focal zones spanning roughly 0 to 65 mm; pulse frequency 1 to 8 Hz.

Radial source parameters: pressure approximately 1 to 5 bar; frequency 1 to 21 Hz; includes a standard musculoskeletal radial transmitter/applicator set.

Required Components

Focused electromagnetic FSW unit

F SW Sepia handpiece

Standard accessory kit: handpiece bracket; water bag; silicon oil; UltraGel coupling gel; power cord; Stand Off I (30 mm); Stand Off II (15 mm); closing ring; operating manual

Mobile stand/cart with second shelf

Tablet with stand (system operation)

Line Item 0002 OrthoPulse Ultra 100 (Radial/Pressure Wave) System

Quantity: 1 Each

Description: Radial/pressure wave therapy system for superficial myofascial and musculoskeletal applications.

Required Components OrthoPulse configuration (Brand Name or Equal):

Radial/pressure wave generator console

Falcon D Actor handpiece

Radial applicator/transmitter set (9) with case

V Actor handpiece

Falcon revision set (replacement wear items: tubes and bullets)

D Actor handpiece brush

EPAT/ESWT patient literature kit

Warranty for Items 1 and 2

Minimum 2 year factory warranty for device(s) and compressor

Minimum 1,000,000 pulse wear warranty

Submission Requirements

Technical Submission: Detailed documentation mapping to each salient characteristic above and FDA PMA evidence for the focused plantar fasciitis indication.

Authorized Distributor Letter: Documentation from the OEM verifying the Offeror is an authorized distributor for the proposed system(s).

Delivery timeline

Evaluation Criteria

Comparative evaluation will be used under RFO Simplified Acquisition Procedures. Award will be made to the lowest priced, technically acceptable quotation that:

Meets all technical requirements and characteristics of the DuoLith SD1 T TOP Ultra (and associated RPW capability) and OrthoPulse Ultra 100

Provides acceptable warranty coverage

Provide Items 1 and Item 2 simultaneously

Demonstrates authorized distribution (OEM provided letter or documentation)

Submission Deadline and Questions

Submission Deadline: September 29, 2026 by 7 PM Eastern Time

Quotes must be emailed to: sherrye.harris@va.gov.

Questions are due no later than September 28, 2026 3:00 PM Eastern Time to: sherrye.harris@va.gov.