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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, nerve, for restless legs syndrome
Definition An external lower extremity nerve stimulator for Restless Legs Syndrome is a prescription device that uses external electrical stimulators and cutaneous electrodes to stimulate nerves in the lower extremity (e.g.,peroneal nerves) and evoke tonic, sustained muscle activation in the legs to reduce the symptoms of Restless Legs Syndrome.
Product CodeQWD
Regulation Number 882.5887
Device Class 2


Premarket Reviews
ManufacturerDecision
NOCTRIX HEALTH, INC.
  GRANTED 1

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