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U.S. Department of Health and Human Services

Product Classification

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Device exercise equipment, powered, emg-triggered
Regulation Description Diagnostic electromyograph.
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.
Physical State EMG sensor, plus other apparatus such as a DC motor, limb orthosis, and connecting cables through which tension is applied.
Technical Method EMG in affected area is sensed, processed, and used as an input to control a DC motor or other actuator that applies a force/torque to move an affected joint through range of motion.
Target Area Typically, such a device will be used on the upper extremity or possibily the lower extremity.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeOAL
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
Submission Type 510(k)
Regulation Number 890.1375
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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