The following data is part of a De Novo classification by Pear Therapeutics, Inc. with the FDA for Reset.
| DeNovo ID | DEN160018 |
| Device Name: | ReSet |
| Classification | Computerized Behavioral Therapy Device For Psychiatric Disorders |
| Applicant | PEAR THERAPEUTICS, INC. 745 Atlantic Ave. Boston, MA 02111 |
| Contact | Nandini Murthy |
| Product Code | PWE |
| CFR Regulation Number | 882.5801 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Neurology |
| Classification Advisory | Neurology |
| Type | Direct |
| Date Received | 2016-05-16 |
| Decision Date | 2017-09-14 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10851580008095 | DEN160018 | 000 |
| 10196439000012 | DEN160018 | 000 |
| 10851580008019 | DEN160018 | 000 |
| 10851580008040 | DEN160018 | 000 |
| 10851580008132 | DEN160018 | 000 |
| 10851580008149 | DEN160018 | 000 |
| 10851580008156 | DEN160018 | 000 |
| 10851580008194 | DEN160018 | 000 |
| 10851580008200 | DEN160018 | 000 |
| 10851580008217 | DEN160018 | 000 |
| 10851580008026 | DEN160018 | 000 |
| 10851580008033 | DEN160018 | 000 |
| 10851580008071 | DEN160018 | 000 |
| 10851580008088 | DEN160018 | 000 |
| 10196439000005 | DEN160018 | 000 |