OHI — Orthosis, Foot Drop Class I
FDA product code OHI covers "Orthosis, Foot Drop", a Class I medical device regulated under 21 CFR 890.3475. Submissions are reviewed by the Physical Medicine panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OHI
- Device Class
- Class I
- Regulation Number
- 890.3475
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Definition
Aid for drop foot or similar disorders which have a lack of ankle dorsiflexion. Indicated for foot raising paresis.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K073521 | musmate | MUSMATE WALKING AID | February 4, 2008 |