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U.S. FDA Medical Device Soft Sacroiliac 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 Soft Sacroiliac Orthosis companies with:

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