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U.S. FDA Medical Device External Brace Ankle 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 Ankle Joint companies with:

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