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U.S. FDA Medical Device Powered Exerciser Requirements

FDA Medical Device Definition: Powered exercise equipment consist of powered 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 powered treadmill, a powered bicycle, and powered parallel bars.

Registrar Corp assists Powered Exerciser companies with:

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