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U.S. FDA Medical Device Prone Scooter Board Requirements

FDA Medical Device Definition: Nonmeasuring exercise equipment consist of devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include a prone scooter board, parallel bars, a mechanical treadmill, an exercise table, and a manually propelled exercise bicycle.

Registrar Corp assists Prone Scooter Board companies with:

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