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US
Last updated May 25, 2026
Information
- Country
- US
- Address
- —
- Website
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- —
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 079705123
Catalogue (32)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| reSET® Mobile App, Android | 1 | FDA UDI | Class II | Active |
| reSET-O™ | 1.1 | FDA UDI | Class II | Unknown |
| reSET-O® Demo Version (Mobile App, iOS) | 1 | FDA UDI | Class II | Active |
| reSET® Demo Version (Mobile App, Android) | 1 | FDA UDI | Class II | Active |
| reSET® Non-Monetary CM | 1 | FDA UDI | Class II | Active |
| reSET-O® Mobile App, Android | 1 | FDA UDI | Class II | Active |
| reSET-O® Introductory Access Limited Version (Mobile App, iOS) | 1 | FDA UDI | Class II | Unknown |
| reSET® | 1 | FDA UDI | Class II | Active |
| reSET® Introductory Access Limited Version (Mobile App, Android) | 1 | FDA UDI | Class II | Unknown |
| reSET® Demo Version (Mobile App, iOS) | 1 | FDA UDI | Class II | Active |
| reSET-O™ | 1.1 | FDA UDI | Class II | Unknown |
| reSET-O® Introductory Access Limited Version | 1 | FDA UDI | Class II | Unknown |
| reSET-O® Demo Version (Mobile App, Android) | 1 | FDA UDI | Class II | Active |
| reSET-O® Introductory Access Limited Version (Mobile App, Android) | 1 | FDA UDI | Class II | Unknown |
| reSET® Introductory Access Limited Version | 1 | FDA UDI | Class II | Unknown |
| reSET-O® | 1 | FDA UDI | Class II | Active |
| reSET® Introductory Access Limited Version (Mobile App, iOS) | 1 | FDA UDI | Class II | Unknown |
| reSET® | 1.4.6 | FDA UDI | Class II | Unknown |
| reSET® | 1 | FDA UDI | Class II | Active |
| reSET® | 1.5 | FDA UDI | Class II | Unknown |
| reSET-O® Mobile App, iOS | 1 | FDA UDI | Class II | Active |
| reSET® | 1.4 | FDA UDI | Class II | Unknown |
| reSET-O® Demo Version | 1 | FDA UDI | Class II | Active |
| reSET® Demo Version | 1 | FDA UDI | Class II | Active |
| reSET® | 1.5 | FDA UDI | Class II | Unknown |
| reSET-O® | 1 | FDA UDI | Class II | Active |
| reSET-O® Non-Monetary CM | 1 | FDA UDI | Class II | Active |
| Somryst™ | 1 | FDA UDI | Class II | Active |
| reSET® Mobile App, iOS | 1 | FDA UDI | Class II | Active |
| reSet | DEN160018 | FDA 510(k) | Class II | Active |
| reSET-O | K173681 | FDA 510(k) | Class II | Active |
| Somryst | K191716 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 7, 2021 | Z-1926-2021 | — | terminated | Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the UDS results. Positive UDS results should not have resulted in access to a wheel spin. |
| Jun 7, 2021 | Z-1925-2021 | — | terminated | Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the UDS results. Positive UDS results should not have resulted in access to a wheel spin. |