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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 psychiatric 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 2

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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