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reSET-O™

PEAR THERAPEUTICS, INC. · Model 1.1 · UDI-DI 10851580008064

PWE Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

reSET-O Mobile Application runs on Android. reSET-O is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only Mobile Medical Application. Limitations of Use: reSET-O has not been shown to decrease illicit drug use or improve abstinence in patients with OUD.

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.