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U.S. FDA Medical Device Crutch Requirements

FDA Medical Device Definition: A crutch is a device intended for medical purposes for use by disabled persons to provide minimal to moderate weight support while walking.

Registrar Corp assists Crutch companies with:

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