The following data is part of a premarket notification filed by Pear Therapeutics, Inc. with the FDA for Reset-o.
| Device ID | K173681 | 
| 510k Number | K173681 | 
| Device Name: | ReSET-O | 
| Classification | Computerized Behavioral Therapy Device For Psychiatric Disorders | 
| Applicant | Pear Therapeutics, Inc. 745 Atlantic Ave. Boston, MA 02111 | 
| Contact | Yuri Maricich | 
| Correspondent | Nandini Murthy Pear Therapeutics, Inc. 745 Atlantic Ave. Boston, MA 02111 | 
| Product Code | PWE | 
| CFR Regulation Number | 882.5801 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2017-12-01 | 
| Decision Date | 2018-12-10 | 
| Summary: | summary | 
| Device Identifier | submissionNumber | Supplement | 
|---|---|---|
| 10851580008125 | K173681 | 000 | 
| 00850074433026 | K173681 | 000 | 
| 10196439000029 | K173681 | 000 | 
| 10196439000036 | K173681 | 000 | 
| 10851580008163 | K173681 | 000 | 
| 10851580008170 | K173681 | 000 | 
| 10851580008187 | K173681 | 000 | 
| 10851580008224 | K173681 | 000 | 
| 10851580008231 | K173681 | 000 | 
| 10851580008248 | K173681 | 000 | 
| 10851580008057 | K173681 | 000 | 
| 10851580008064 | K173681 | 000 | 
| 10851580008101 | K173681 | 000 | 
| 10851580008118 | K173681 | 000 | 
| 00850074433019 | K173681 | 000 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  RESET-O  87925200  not registered Live/Pending | Pear Therapeutics, Inc. 2018-05-17 | 
|  RESET-O  87925189  not registered Live/Pending | Pear Therapeutics, Inc. 2018-05-17 | 
|  RESET-O  87635226  5740689 Live/Registered | Pear Therapeutics, Inc. 2017-10-05 |