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U.S. FDA Medical Device Abdominal 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 Abdominal Orthosis companies with:

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