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U.S. FDA Medical Device Corrective Shoe Orthosis 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 Corrective Shoe Orthosis companies with:

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