510(k) DEN160018
DEN160018 is an FDA 510(k) premarket notification submitted by Pear Therapeutics, Inc. for the device "reSet". The FDA issued a decision of De Novo granted on Sep 14, 2017. The device falls under product code PWE (Computerized Behavioral Therapy Device For Substance Use Disorders), a Class II device regulated under 21 CFR 882.5801. Pear Therapeutics, Inc. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- DENG (De Novo granted)
- Decision Date
- Sep 14, 2017
- Date Received
- May 16, 2016
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Computerized Behavioral Therapy Device For Substance Use Disorders
- Device Class
- Class II
- Regulation Number
- 882.5801
- Review Panel
- NE
- Submission Type
- 510(k)
The device is intended to provide cognitive behavioral therapy to treat substance use disorder.