Upper Limb Bypass Prothesis System to include TASKA CX
Closed Pre-Solicitation Posted
- Solicitation number
- 75F40126SSN133891
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 339113 Surgical Appliance and Supplies Manufacturing
- PSC
- 6640 Laboratory Equipment And Supplies
- Place of performance
- United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Food and Drug Administration's Division of Biomedical Physics is conducting a sources sought notice for an upper limb bypass prosthesis system featuring a TASKA CX prosthetic hand, with responses due by 2:00 PM Central Time on May 29, 2026. This is a market survey only; no contract will be awarded and no reimbursement will be provided for response costs.
The FDA targets small business concerns under NAICS 339113 (Surgical Appliances and Supplies Manufacturing) with a 750-employee size standard, though all interested parties may respond. The system must deliver to FDA-CDRH in Silver Spring, Maryland.
Minimum technical requirements include a 7-inch myoelectric hand with independently articulating digits, IP67 water resistance, electronically multi-positional thumb, wrist flexion, Quick Disconnect wrist, and 2-site proportional programmable control using removable suction EMG electrodes. The system may be configured as a direct limb extension or with an angled offset for functional positioning. Respondents must demonstrate certified prosthetist fabrication with prior myoelectric bypass prosthesis experience, provide staff training, offer pattern recognition control option capability, and provide a minimum one-year full hardware warranty with free replacement for manufacturing defects and shipping costs.
Capability statements must include company information, past performance within three years demonstrating myoelectric bypass prosthesis fabrication experience, technical specifications, GSA Schedule or government contract information if applicable, warranty terms, manufacturing location, and informational pricing. Submit responses by email to timothy.walbert@fda.hhs.gov, referencing SSN 75F40126SSN133891.
Notice text
This is a Sources Sought Notice for an upperlimb bypass prosthesis system to include a TASKA CX. Please see attached 75F40126SSN133891.
Files
| File | Type | Posted |
|---|---|---|
| 75F40126SSN133891.pdf |
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