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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transcutaneous nerve stimulator for adhd
Definition A transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD) is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.
Product CodeQGL
Regulation Number 882.5898
Device Class 2


Premarket Reviews
ManufacturerDecision
BISTOS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEUROSIGMA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NU EYNE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

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