COUNTER-ROTATION SYSTEM
Device Facts
| Record ID | K821256 |
|---|---|
| Device Name | COUNTER-ROTATION SYSTEM |
| Applicant | The Langer Group |
| Product Code | ITN · Physical Medicine |
| Decision Date | Jun 23, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3675 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A Denis Brown splint is a device intended for medical purposes to immobilize the foot. It is used on young children with tibial torsion (excessive rotation of the lower leg) or club foot.
