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U.S. FDA Medical Device Knee Cage Requirements

FDA Medical Device Definition: A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.

Registrar Corp assists Knee Cage companies with:

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