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U.S. FDA Medical Device Thoracic Orthosis Requirements

FDA Medical Device Definition: A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.

Registrar Corp assists Thoracic Orthosis companies with:

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