Upper Limb Bypass Prothesis System to include TASKA CX

Quick Summary

The U.S. Food and Drug Administration (FDA), specifically the Division of Biomedical Physics (DBP) and Office of Science and Engineering Labs (OSEL), has issued a Sources Sought Notice for an upper limb bypass prosthesis system that includes a TASKA CX or equal terminal hand. This market survey aims to identify qualified sources capable of providing a system for collecting data on emerging prosthetic technologies. Capability statements are due by May 29, 2026.

Purpose & Scope

The FDA requires this system to enable accurate simulation of prosthesis control by individuals without upper limb loss or difference, using a bypass prosthesis. The goal is to support research and data collection on human-device interaction with advanced prosthetic technologies.

Key Requirements & Deliverables

The required system includes:

• A bypass prosthetic system with a TASKA CX or equal terminal hand.
• Fabrication and integration of the bypass prosthesis and hand by an organization with certified prosthetists and prior experience in myoelectric bypass prosthesis fabrication.
• An option for transitioning the control method to pattern recognition using the same socket prosthesis.
• Staff familiarization, use, and routine maintenance training on the TASKA CX bypass system.
• A minimum one-year full hardware warranty from the date of Government acceptance, including full device replacement for manufacturing defects or operational failures during normal use, and covering all associated shipping costs.

Salient characteristics for the TASKA CX or "Equal" Terminal Device (Hand) include:

• 7 ¾” myoelectric hand with independently articulating digits.
• Lateral/rotational compliance and IP67 water resistance.
• Electronically multi-positional thumb and wrist flexion.
• Includes all necessary cables, chargers, and batteries.
• Quick Disconnect wrist.
• Attachable to a below-elbow non-amputee carbon fiber socket with a removable forearm shell.
• Integrated power switch and charging port on the socket.
• Control method: 2-site proportional programmable control with suction EMG electrodes.

Submission Details

Interested firms should submit capability statements via email to timothy.walbert@fda.hhs.gov by May 29, 2026, before 2:00 PM (Central Time). The subject line must reference "75F40126SSN133891". Statements should demonstrate the ability to meet minimum performance requirements and include:

• Business information.
• Past performance (last 3 years) related to similar products/services.
• Descriptive literature and technical information.
• Service initiation capability.
• GSA Schedule/BIC contract information (if applicable).
• Subcontracting opportunities (if applicable).
• Commercial warranty/payment terms.
• Place of product manufacture. Informational pricing is requested but not required.

Eligibility & Set-Aside

The NAICS Code is 339113 - Surgical Appliances and Supplies Manufacturing (Small Business Size Standard: 750 employees). While no specific set-aside is designated for this market research, small businesses are strongly encouraged to respond, as are other than small business concerns.

Important Notes

This is a Sources Sought Notice for market research purposes only and is not a solicitation or Request for Quotation (RFQ). No contract will be awarded from this notice, and the Government will not reimburse costs associated with providing information. Telephone calls will not be accepted, and responses with weblinks will not be opened. Do not include proprietary, classified, confidential, or sensitive information. The Government reserves the right to use any non-proprietary technical information in future solicitations.