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.
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.
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