DeviceClearance

Product code OAL— Physical Medicine

MYOMO E100

Classification name
Exercise Equipment, Powered, Emg-Triggered
Device class
Class 2
Regulation
21 CFR 890.1375
Advisory panel
Physical Medicine
Total cleared
1
First cleared
Most recent

FDA classification definition

“To provide rehabilitation (e.G., increasing range of motion, muscle re-education) through emg-triggered powered exercise. Increasing range of motion and muscle re-education.”

— U.S. Food and Drug Administration, device classification record for product code OAL under 21 CFR 890.1375, via openFDA

Market context for product code OAL

FDA has cleared 1 device under product code OAL, all in 2007, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OAL

Recent clearances under product code OAL

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