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U.S. FDA Medical Device Mechanical Walker Requirements

FDA Medical Device Definition: A mechanical walker is a four-legged device with a metal frame intended for medical purposes to provide moderate weight support while walking. It is used by disabled persons who lack strength, good balance, or endurance.

Registrar Corp assists Mechanical Walker companies with:

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