DEN160018 is an FDA 510(k) submission for the reSet. This device is classified as a Computerized Behavioral Therapy Device For Substance Use Disorders (Class II - Special Controls, product code PWE).
Submitted by Pear Therapeutics, Inc. (Boston, US). The FDA issued a Not Cleared (DENG) decision on September 14, 2017.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5801. The Device Is Intended To Provide Cognitive Behavioral Therapy To Treat Substance Use Disorder..
| 510(k) Number | DEN160018 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | May 16, 2016 |
| Decision Date | September 14, 2017 |
| Days to Decision | 486 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | PWE - Computerized Behavioral Therapy Device For Substance Use Disorders |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5801 |
| Definition | The Device Is Intended To Provide Cognitive Behavioral Therapy To Treat Substance Use Disorder. |