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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrical tongue stimulator to treat motor deficits
Definition An electrical tongue nerve stimulator to treat motor deficits is a prescription device that consists of a non-implantable apparatus to generate electrical pulses for stimulation of the nerves in the tongue to provide treatment of motor deficits.
Product CodeQCF
Regulation Number 882.5889
Device Class 2


Premarket Reviews
ManufacturerDecision
HELIUS MEDICAL, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

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