DeviceClearance

Product code OHI— Physical Medicine

MUSMATE WALKING AID

Classification name
Orthosis, Foot Drop
Device class
Class 1
Regulation
21 CFR 890.3475
Advisory panel
Physical Medicine
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code OHI under 21 CFR 890.3475, via openFDA

Market context for product code OHI

FDA has cleared 1 device under product code OHI, all in 2008, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code OHI

Recent clearances under product code OHI

Data sourced from openFDA. This site is unofficial and independent of the FDA.