Product code OHI
- Device name
- Orthosis, Foot Drop
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3475
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Aid for drop foot or similar disorders which have a lack of ankle dorsiflexion. Indicated for foot raising paresis.
- Source
- FDA openFDA device classification dataset