OHI

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Orthosis, Foot Drop

Device class

Class I (low risk)

Regulation

21 CFR 890.3475

Medical specialty

Physical Medicine

Flags

GMP exempt

FDA definition

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

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