OHI

Orthosis, Foot Drop

Product code

OHI

Device name

Orthosis, Foot Drop

Device class

Class 1

21 CFR

21 CFR 890.3475

Medical specialty

Physical Medicine

Marketing pathway

510(K) Exempt

Flag

GMP exempt

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

Aid for drop foot or similar disorders which have a lack of ankle dorsiflexion. Indicated for foot raising paresis.

Definition text from the FDA device classification database (U.S. federal government work, public domain).