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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodeOAL
Regulation Number 890.1375
Device Class 2


Premarket Reviews
ManufacturerDecision
MYOMO, INC.
  SUBSTANTIALLY EQUIVALENT 1

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