FDA product code OHI: Orthosis, Foot Drop
OHI is the FDA product code for orthosis, foot drop. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under OHI. The average 510(k) review took 52 days (median 52).
Definition
Aid for drop foot or similar disorders which have a lack of ankle dorsiflexion. Indicated for foot raising paresis.
Classification
| Field | Value |
|---|---|
| Device name | Orthosis, Foot Drop |
| Device class | Class I |
| Regulation | 21 CFR 890.3475 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every OHI clearance
Top OHI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Musmate, Ltd. | 1 | 2008-02-04 |
Most recent OHI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K073521 | Musmate, Ltd. | MUSMATE WALKING AID | 2008-02-04 | 52 |
Recalls for OHI devices
openFDA lists no recalls for product code OHI.
Frequently asked questions
What is FDA product code OHI?
OHI is the FDA product code for orthosis, foot drop. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel.
What device class is OHI?
Class I, regulation 21 CFR 890.3475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OHI?
Across 1 cleared submissions the average was 52 days from receipt to decision (median 52).
Which companies have the most OHI clearances?
Musmate, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OHI
- Run a recall and safety report across every OHI manufacturer
- Watch product code OHI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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