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U.S. FDA Medical Device Exercise Components Requirements

FDA Medical Device Definition: An exercise component is a device that is used in conjunction with other forms of exercise and that is intended for medical purposes, such as to redevelope muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include weights, dumbbells, straps, and adaptive hand mitts.

Registrar Corp assists Exercise Components companies with:

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