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reSET-O® Introductory Access Limited Version (Mobile App, Android)

PEAR THERAPEUTICS, INC. · Model 1 · UDI-DI 10851580008187

PWE Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

reSET-O® Mobile Application running on Android. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Introductory Access Limited Version provides limited access to the reSET-O product.

Recalls

Date	Firm	Reason
2021-06-07	Pear Therapeutics, Inc.	Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the UDS results. Positi
2021-06-07	Pear Therapeutics, Inc.	Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the UDS results. Positi

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.