reSET®

PEAR THERAPEUTICS, INC. · Model 1 · UDI-DI 10196439000005

PWE Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12-week (90 days) prescriptiononly treatment for patients with Substance Use Disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to: increase abstinence from a patient’s substances of abuse during treatment, and increase retention in the outpatient treatment program. This configuration of reSET is intended to provide virtual incentives as well as monetary incentives to the patients based on the Contingency management system.

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.