← FDA Medical Device Classifications
Orthosis, Foot Drop
OHI · Class I — Low Risk (general controls) · Physical Medicine · 21 CFR 890.3475
Classification
- FDA Product Code
OHI- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 890.3475
- Review panel
- PM
- Medical specialty
- Physical Medicine
- Submission type
- 4
- GMP exempt
- Y
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Aid for drop foot or similar disorders which have a lack of ankle dorsiflexion. Indicated for foot raising paresis.
Market data
- Cleared 510(k) submissions
- 1
- Registered establishments
- 72
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown