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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device vibratory counter-stimulation
Regulation Description Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.
Definition A vibratory counter-stimulation device is a prescription device that provides electrically powered mechanical vibration to improve the quality of sleep in patients with primary Restless Legs Syndrome.
Product CodeOVP
Regulation Number 882.5894
Device Class 2


Premarket Reviews
ManufacturerDecision
SENSORY MEDICAL, INC
  GRANTED 1

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