36C24126Q0850.docx

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

GENERAL INFORMATION

SET-ASIDE

VA Boston Healthcare System Contracting Officer (90C) 940 Belmont Street Brockton MA 02301

POINT OF CONTACT*

Contract Specialist Sherrye Harris Sherrye.Harris@va.gov

PLACE OF PERFORMANCE

200 Springs Street

Bedford, MA

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

DESCRIPTION

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

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

C. 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.

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

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

F. 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.

Combined Synopsis/Solicitation Notice