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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
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
PEAR THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 1 1

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

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