reSET-O®

FDA UDI

Class II (US FDA UDI)

by Pear Therapeutics, Inc.

Identity

Trade Name: reSET-O® FDA UDI
Generic Name: Psychological assessment software FDA UDI
Device Name: 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 digital therapeutic. This configuration of reSET-O 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-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 digital therapeutic. This configuration of reSET-O 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: 10196439000029 FDA UDI
510(k) Number: K173681 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-O® 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

K173681 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 711ad631-d3b6-452a-b9e7-315b0f16eeb2 35 fields · synced Jun 8, 2026