Device recall
Z-1926-2021: reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as…
FDA device recall · Class II · Pear Therapeutics, Inc.
Key facts
| Recall number (Z-number) | Z-1926-2021 |
|---|---|
| Recall event | 88061 |
| Product | reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment. |
| Product code | PWE |
| Recalling firm | Pear Therapeutics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 14, 2023 |
| 510(k) numbers | K173681 |
| FEI number | 3014109807 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database