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U.S. FDA Medical Device Nonpowered Dynamometer Requirements


FDA Medical Device Definition: A nonpowered dynamometer is a mechanical device intended for medical purposes to measure the pinch and grip muscle strength of a patient's hand.

Registrar Corp assists Nonpowered Dynamometer companies with:

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