FDA product code · Physical medicine
Orthosis, Foot Drop
FDA lists OHI as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 890.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 2008. No recall names this code.
Aid for drop foot or similar disorders which have a lack of ankle dorsiflexion. Indicated for foot raising paresis.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OHI at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · OHI
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · OHI
Too few OHI 510(k)s in any year since 2007 to give a median.
Recalls per year · OHI
No recall names OHI since 2007.
Adverse event reports per year · OHI
1in 2020
MAUDE reports naming product code OHI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in OHI? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportRelated product codes
Other codes under 21 CFR 890.3475.