U.S. FDA Medical Device Elastic Stocking Requirements
FDA Medical Device Definition: A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.
FDA Elastic Stocking Label Requirements and Exceptions
FDA Elastic Stocking Import Information
FDA Elastic Stocking Detentions (Elastic Stocking Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Elastic Stocking Manufacturers (Elastic Stocking Suppliers)
- Elastic Stocking Distributors
- Elastic Stocking Processors
- Elastic Stocking Repackers
- Elastic Stocking Relabelers
- Elastic Stocking Exporters
- Elastic Stocking Importers
For more information about Elastic Stocking 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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