Identity
- Trade Name
- reSET® Mobile App, iOS FDA UDI
- Generic Name
- Mental health/function therapeutic software, screen-viewed FDA UDI
- Device Name
- reSET® Mobile Application running on iOS. 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) prescription-only 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. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- reSET® Mobile Application running on iOS. 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) prescription-only 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10851580008088 FDA UDI
- 510(k) Number
- DEN160018 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
- 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
Category: Mental health/function therapeutic software, screen-viewed
reSET® Mobile App, iOS by Pear Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Mental health/function therapeutic software, screen-viewed.
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- PursueCare RESET-O — HARVEST BIO LLC · Class II
Cleared under the same submission
DEN160018 also covers:
- PursueCare RESET — HARVEST BIO LLC
- PursueCare RESET — HARVEST BIO LLC
- reSET® — Pear Therapeutics, Inc.
- reSET® — Pear Therapeutics, Inc.
- reSET® Demo Version — Pear Therapeutics, Inc.
- reSET® Demo Version (Mobile App, Android) — Pear Therapeutics, Inc.
- reSET® Demo Version (Mobile App, iOS) — Pear Therapeutics, Inc.
- reSET® Mobile App, Android — Pear Therapeutics, Inc.
- reSET® Non-Monetary CM — Pear Therapeutics, Inc.
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 6c90b961-5b2e-41e3-86ca-31326bc51dcc 34 fields · synced May 29, 2026