510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OHIClass I

Orthosis, Foot Drop

21 CFR 890.3475 / Physical Medicine
FDA source (opens on fda.gov)

OHI is the FDA product code for Orthosis, Foot Drop, a class I device type, regulated under 21 CFR 890.3475. FDA's definition for this code reads: "Aid for drop foot or similar disorders which have a lack of ankle dorsiflexion. Indicated for foot raising paresis". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OHI
Device name
Orthosis, Foot Drop
FDA definition
Aid for drop foot or similar disorders which have a lack of ankle dorsiflexion. Indicated for foot raising paresis.
Regulation
21 CFR 890.3475
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code OHI

By decision year
1 clearance under product code OHI with a decision year between 2008 and 2008, 2008 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OHI by decision year
YearClearances
20081

Applicants with the most clearances

Product code OHI
Applicants holding the most 510(k) clearances under product code OHI
ApplicantClearances
Musmate, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 74 companies shown, in name order