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U.S. FDA Medical Device Cane Requirements

FDA Medical Device Definition: A cane is a device intended for medical purposes that is used to provide minimal weight support while walking. Examples of canes include the following: A standard cane, a forearm cane, and a cane with a tripod, quad, or retractable stud on the ground end.

Registrar Corp assists Cane companies with:

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