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U.S. FDA Medical Device Nonpowered Goniometer Requirements


FDA Medical Device Definition: A nonpowered goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints.

Registrar Corp assists Nonpowered Goniometer companies with:

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