PWE
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Computerized Behavioral Therapy Device For Substance Use Disorders
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5801
- Medical specialty
- Neurology
- FDA definition
- The device is intended to provide cognitive behavioral therapy to treat substance use disorder.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| reSET-O (K173681) | Pear Therapeutics, Inc. | 2018-12-10 |
| reSet (DEN160018) | Pear Therapeutics, Inc. | 2017-09-14 |
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