SAM #75F40126SSN133891

FDA Seeks Upper Limb Bypass Prosthesis System with TASKA CX or Equivalent

The U.S. Food and Drug Administration (FDA) is conducting market research for an upper limb bypass prosthesis system for use by the Division of Biomedical Physics and the Human-Device Interaction Lab. - Government Buyer: - U.S. Food and Drug Administration (FDA), Division of Biomedical Physics (DBP), Human-Device Interaction Lab, Office of Science and Engineering Labs (OSEL) - OEMs and Vendors: - TASKA Prosthetics (TASKA CX hand specified or equivalent) - Products/Services Requested: - Bypass prosthetic system including a TASKA CX or equivalent myoelectric terminal hand - Must feature 7 independently articulating digits, lateral/rotational compliance, IP67 water resistance, electronically multi-positional thumb, wrist flexion, quick disconnect wrist, and all necessary cables, chargers, and batteries - Includes a below elbow non-amputee carbon fiber socket with removable forearm shell - 2-site proportional programmable control with suction EMG electrodes removable from a fitted cloth sleeve - Integrated power switch and charging port in the socket - Fabrication by certified prosthetists with prior experience fitting the TASKA CX hand - One-year full hardware warranty (including replacement and shipping) - Training for staff on familiarization, use, and routine maintenance of the TASKA CX bypass system - Unique/Notable Requirements: - System must allow simulation of prosthesis control for non-amputees - Fabrication and fitting must be performed by certified prosthetists with documented experience with the TASKA CX hand - Training and warranty are mandatory components - Place of Performance/Delivery: - Delivery to U.S. FDA-CDRH, 10903 New Hampshire Avenue, Bldg. 62, Room 4215, Silver Spring, MD 20993-0002

Description

This is a Sources Sought Notice for an upperlimb bypass prosthesis system to include a TASKA CX.  Please see attached 75F40126SSN133891.

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