Product code OAL

Device name

Exercise Equipment, Powered, Emg-Triggered

Medical specialty

Physical Medicine

Device class

2

Regulation number

890.1375

Review panel

PM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset