Upper Limb Bypass Prothesis System to include TASKA CX

The U.S. Food and Drug Administration’s Office of Acquisition and Grant Services is conducting market research through a Sources Sought Notice for an upper limb bypass prosthesis system incorporating the TASKA CX or an equivalent myoelectric terminal hand. This notice, issued under solicitation number 75F40126SSN133891 and posted on May 21, 2026, with a response deadline of May 29, 2026, is not a solicitation for proposals or a contract award opportunity but is intended to gather detailed industry capabilities to inform future procurement decisions. Respondents must submit capability statements exclusively via email to Timothy Walbert at timothy.walbert@fda.hhs.gov, referencing the solicitation number in the subject line, and must avoid including any weblinks, proprietary data, or confidential information. The system must consist of a (7 1/4) inch myoelectric hand with independently articulating digits, lateral and rotational compliance, IP67 water resistance, an electronically multi-positional thumb, wrist flexion, and a quick disconnect wrist. Integration is required with a below-elbow non-amputee carbon fiber socket featuring a removable forearm shell, integrated power switch with charging port, and removable suction EMG electrodes housed in a fitted cloth sleeve—not embedded directly into the socket. All necessary cables, chargers, and batteries for operation and charging must be included, along with training for staff on use and routine maintenance, and an option to transition control from proportional EMG to pattern recognition using the same socket. Manufacturers or vendors must be certified prosthetists with prior experience in myoelectric bypass prosthesis fabrication. Respondents must provide their SAM Unique Entity Identifier, business size status under NAICS code 339113 (Surgical Appliances and Supplies Manufacturing), and if applicable, the manufacturer’s UEI and size status. Large businesses must disclose potential subcontracting opportunities for small businesses. The Buy American Act and Made in America compliance must be addressed by identifying the place of manufacturing or service performance. While no formal pricing or contract value is being solicited, informational pricing is requested for market analysis. The system must be capable of a one-year full hardware warranty from government acceptance, including full replacement at no cost for manufacturing defects or operational failures under normal use, with all shipping costs covered. Responses must demonstrate actual capability through detailed technical evidence, not general assertions.