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reSET-O™

FDA UDI

Class II (US FDA UDI)

by Pear Therapeutics, Inc.

Identity

Trade Name
reSET-O™ FDA UDI
Generic Name
Mental health/function therapeutic software, screen-viewed FDA UDI
Device Name
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. FDA UDI
Model / Reference
1.1 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
N/A FDA UDI
Primary DI / UDI-DI
10851580008064 FDA UDI
510(k) Number
K173681 FDA UDI
FDA Product Code
PWE FDA UDI
GMDN Term
Mental health/function therapeutic software, screen-viewed FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5801 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

Cleared under the same submission

K173681 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pear Therapeutics, Inc.

Sources (1)

  • FDA UDI 902cf08a-af6e-4fb2-ab22-a30b9097a495 36 fields · synced Jun 1, 2026