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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device computerized behavioral therapy device for insomnia
Regulation Description Computerized behavioral therapy device for psychiatric disorders.
Definition The device is intended to provide cognitive behavioral therapy to treat insomnia.
Product CodeQVO
Regulation Number 882.5801
Device Class 2


Premarket Reviews
ManufacturerDecision
BIG HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Sleep Dysfunction 1 1
Neck Pain 1 1
Muscular Rigidity 1 1
Anxiety 1 1
Convulsion/Seizure 1 1

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