Identity
- Trade Name
- reSET-O® Demo Version (Mobile App, Android) FDA UDI
- Generic Name
- Mental health/function therapeutic software, screen-viewed FDA UDI
- Device Name
- reSET-O® Mobile Application running on Android. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Demo Version provides demonstration access to various prescription versions of the reSET-O product and is not intended for patients. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- reSET-O® Mobile Application running on Android. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Demo Version provides demonstration access to various prescription versions of the reSET-O product and is not intended for patients. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10851580008248 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
- 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-O® Demo Version (Mobile App, Android) 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:
- PursueCare RESET-O — HARVEST BIO LLC
- PursueCare RESET-O — HARVEST BIO LLC
- reSET-O® — Pear Therapeutics, Inc.
- reSET-O® — Pear Therapeutics, Inc.
- reSET-O® Demo Version — Pear Therapeutics, Inc.
- reSET-O® Demo Version (Mobile App, iOS) — Pear Therapeutics, Inc.
- reSET-O® Mobile App, Android — Pear Therapeutics, Inc.
- reSET-O® Mobile App, iOS — Pear Therapeutics, Inc.
- reSET-O® 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 0ab957a8-ee9a-4e94-a651-2aefe5423333 34 fields · synced May 30, 2026