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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device digital therapy device to reduce sleep disturbance for psychiatric conditions
Definition A digital therapy device to reduce sleep disturbance for psychiatric conditions is a prescription device that is intended to provide stimulation using a general purpose computing platform to reduce sleep disturbance in patients who experience this symptom due to psychiatric conditions such as nightmare disorder or post traumatic stress disorder (PTSD).
Product CodeQMZ
Regulation Number 882.5705
Device Class 2


Premarket Reviews
ManufacturerDecision
NIGHTWARE, INC
  GRANTED 1

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
High Blood Pressure/ Hypertension 1 1

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