Orthosis, Foot Drop
The Foot Drop Orthosis is a device designed to aid patients with foot drop or similar disorders involving a lack of ankle dorsiflexion, indicated specifically for foot-raising paresis, helping patients achieve a more normal gait pattern. Classified as FDA Class 1 under regulation 21 CFR 890.3475 within the Physical Medicine medical specialty, it is subject to general controls only and is GMP-exempt, meaning it qualifies for an exemption from certain good manufacturing practice requirements. The product code is OHI. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OHI
- Device Class
- FDA class 1
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
Definition
Aid for drop foot or similar disorders which have a lack of ankle dorsiflexion. Indicated for foot raising paresis.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K073521 | MUSMATE WALKING AID | Feb 04, 2008 | Substantially Equivalent | Musmate, Ltd. |
FEI Numbers
This FDA classification entry is associated with 74 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 74 registration numbers. Click on an entry to view related FDA registrations.