reSET®

FDA UDI

Class II (US FDA UDI)

by Pear Therapeutics, Inc.

Identity

Trade Name: reSET® FDA UDI
Generic Name: Psychological assessment software FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 1 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: N/A FDA UDI
Primary DI / UDI-DI: 10196439000005 FDA UDI
510(k) Number: DEN160018 FDA UDI
FDA Product Code: PWE FDA UDI
GMDN Term: Psychological assessment software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5801 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Psychological assessment software

reSET® by Pear Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

DEN160018 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Pear Therapeutics, Inc.

Sources (1)

FDA UDI 9f629c8c-3887-4837-930f-b63d09876285 35 fields · synced May 30, 2026