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reSET® Introductory Access Limited Version (Mobile App, iOS)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- reSET® Introductory Access Limited Version (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 a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Introductory Access Limited Version provides limited access to the reSET product. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- reSET® Mobile Application running on iOS. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Introductory Access Limited Version provides limited access to the reSET product. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10851580008149 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
- 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® Introductory Access Limited Version (Mobile App, iOS) by Pear Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID
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® 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 ca6ec310-c69f-4135-8bf2-bfc2eaa07492 35 fields · synced May 30, 2026