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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electromagnetic stimulator for healthy muscle stimulation
Regulation Description Powered muscle stimulator.
Definition A device used for other than medical purposes to induce an electrical current to the body using a time-varying magnetic field to temporarily increase local blood flow and stimulate healthy muscles. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions.
Product CodeSGT
Regulation Number 890.5850
Device Class 2


Premarket Reviews
ManufacturerDecision
AURA WELLNESS, LLC
  SUBSTANTIALLY EQUIVALENT 1

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