SORBOTHANE
Device Facts
| Record ID | K810228 |
|---|---|
| Device Name | SORBOTHANE |
| Applicant | Hamilton Kent |
| Product Code | KNP · Physical Medicine |
| Decision Date | Feb 10, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3475 |
| Device Class | Class 1 |
Regulatory Classification
Identification
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.
