Identity
- Trade Name
- reSET® Demo Version (Mobile App, Android) FDA UDI
- Generic Name
- Mental health/function therapeutic software, screen-viewed FDA UDI
- Device Name
- reSET® Mobile Application running on Android. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Demo Version provides demonstration access to various prescription versions of the reSET product and is not intended for patients. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- reSET® Mobile Application running on Android. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Demo Version provides demonstration access to various prescription versions of the reSET product and is not intended for patients. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10851580008217 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® 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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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, iOS) — Pear Therapeutics, Inc.
- reSET® Mobile App, Android — Pear Therapeutics, Inc.
- reSET® Mobile App, iOS — 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 c3456f6d-d84a-491d-8e5e-94a5a17c9d50 34 fields · synced Jun 1, 2026