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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transcranial magnetic stimulation system for post traumatic stress disorder (ptsd)
Regulation Description Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
Definition External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields in brain areas outside cerebral cortex (e.g., cerebellum).
Product CodeSIG
Regulation Number 882.5802
Device Class 2


Premarket Reviews
ManufacturerDecision
WAVE NEUROSCIENCE
  SUBSTANTIALLY EQUIVALENT 1

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