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U.S. FDA Medical Device Powered Parallel Bars 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 Parallel Bars companies with:

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