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 |