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

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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…

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