K173681 is an FDA 510(k) clearance for the reSET-O. 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 Cleared decision on December 10, 2018, 374 days after receiving the submission on December 1, 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 | K173681 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 2017 |
| Decision Date | December 10, 2018 |
| Days to Decision | 374 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| 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. |