Pear Therapeutics, Inc.

FDA Regulatory Profile

Pear Therapeutics, Inc. appears in FDA public data with 2 recalls, 3 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1925-2021, Class II) was initiated on June 7, 2021. Its most recent 510(k) clearance was granted on March 23, 2020.

Summary

Total Recalls
2
510(k) Clearances
3
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1925-2021Class IIreSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuseJune 7, 2021
Z-1926-2021Class IIreSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuJune 7, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K191716SomrystMarch 23, 2020
K173681reSET-ODecember 10, 2018
DEN160018reSetSeptember 14, 2017