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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 substance use disorders
Definition The device is intended to provide cognitive behavioral therapy to treat substance use disorder.
Product CodePWE
Regulation Number 882.5801
Device Class 2


Premarket Reviews
ManufacturerDecision
PEAR THERAPEUTICS, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 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
Arrhythmia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Pear Therapeutics, Inc. II Jun-21-2021
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