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U.S. FDA Medical Device External Brace Knee Joint Requirements


FDA Medical Device Definition: A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.

Registrar Corp assists External Brace Knee Joint companies with:

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