Identity
- Trade Name
- PursueCare RESET FDA UDI
- Generic Name
- Mental health/function therapeutic software, screen-viewed FDA UDI
- Device Name
- RESET Mobile Application runs on iOS and is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older. FDA UDI
- Model / Reference
- 2.0.2 FDA UDI
- Description
- RESET Mobile Application runs on iOS and is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850074433002 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
PursueCare RESET by Harvest Bio Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mental health/function therapeutic software, screen-viewed.
- reSET® Demo Version (Mobile App, Android) — Pear Therapeutics, Inc. · Class II
- AspyreRx — Better Therapeutics · Class II
- reSET-O® Demo Version — Pear Therapeutics, Inc. · Class II
- Somryst — Nox Medical ehf. · Class II
- Mahana IBS — Mahana Therapeutics, Inc. · Class II
- MamaLift Plus — Curio Digital Therapeutics, Inc. · Class II
- reSET-O® Demo Version (Mobile App, iOS) — Pear Therapeutics, Inc. · Class II
- Rejoyn — Otsuka Pharmaceutical Development & Commercialization, Inc. · Class II
Cleared under the same submission
DEN160018 also covers:
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Harvest Bio Llc
Sources (1)
- FDA UDI 3b7800ec-b16d-4b68-81ba-376aaa66466c 34 fields · synced May 30, 2026