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U.S. FDA Medical Device Cable Requirements

FDA Medical Device Definition: An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

Registrar Corp assists Cable companies with:

  • FDA Cable Establishment Registration
  • FDA Cable Listing
  • FDA Cable Label Requirements and Exceptions
  • FDA Cable Import Information
  • FDA Cable Detentions (Cable Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Cable Manufacturers (Cable Suppliers)
       - Cable Distributors
       - Cable Processors
       - Cable Repackers
       - Cable Relabelers
       - Cable Exporters
       - Cable Importers
For more information about Cable Medical Devices, simply click below:

U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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