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U.S. FDA Medical Device Non-Measuring Exerciser 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 Non-Measuring Exerciser companies with:

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