Pear Therapeutics, Inc.
Boston, MA, US
Pear Therapeutics, Inc. appears in FDA device records in Boston, MA. FDA records list 3 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Pear Therapeutics, Inc. between 2017 and 2020. The busiest year on record is 2017, with 1. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1926-2021 | reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment. | Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the UDS results. Positive UDS results should not have resulted in access to a wheel spin. | Class II | Terminated | |
| Z-1925-2021 | reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment. | Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the UDS results. Positive UDS results should not have resulted in access to a wheel spin. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain