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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transcranial nerve stimulation device for the treatment of post-traumatic stress disorder associated symptoms
Definition A transcranial nerve stimulation device for the treatment of post-traumatic stress disorder (PTSD) associated symptoms is a prescription, home-use, externally worn device that applies electrical stimulation to a location on the patient’s head. The device is not intended as a stand-alone therapy or to alter usual care treatment.
Product CodeSHX
Regulation Number 882.5807
Device Class 2


Premarket Reviews
ManufacturerDecision
NEUROVALENS LIMITED
  GRANTED 1

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