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.
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.
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