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U.S. FDA Medical Device Arm Support 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 Arm Support companies with:

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