SAM #75F40126Q133891

FDA Solicitation for Complete Upper Limb Prosthetic System with TASKA CX or Equivalent

The U.S. Food and Drug Administration (FDA) Division of Biomedical Physics is seeking a complete, fully assembled bypass upper limb prosthetic system. - Government Buyer: - U.S. Food and Drug Administration (FDA) - Center for Devices and Radiological Health (CDRH) - Division of Biomedical Physics, Office of Science and Engineering Labs (OSEL) - OEMs and Vendors: - TASKA (TASKA CX terminal hand specified) - Equivalent products from other manufacturers are acceptable - Products/Services Requested: - One complete bypass upper limb prosthetic system - Includes TASKA CX or equivalent terminal hand - Myoelectric control - Water resistance - Quick disconnect wrist - All necessary cables, chargers, and batteries - Fabrication by certified prosthetists - Training for FDA staff - Minimum one-year full hardware warranty - Two-year manufacturer warranty from FDA acceptance - Unique/Notable Requirements: - Compliance with Section 508 accessibility standards - Delivery to FDA CDRH in Silver Spring, MD - Firm fixed-price contract set aside for small businesses (NAICS 339113) - Detailed technical and price proposals required - Emphasis on warranties and training

Description

This requirement is for a complete, fully assembled bypass upper limb prosthetic system to include a TASKA CX or equal terminal hand.  Please see the attached PDF file titled FDA 75F40126Q133891.

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