Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati is an AI-enabled medical device from Element Science, Inc., listed by FDA (PMA, P230022) with a decision date of 2025-04-30. Review panel: Cardiovascular.
| FDA submission number | P230022 |
|---|---|
| Pathway | PMA |
| Company | Element Science, Inc. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2025-04-30 |
| Product code | MVK |
| Classification | Wearable Automated External Defibrillator |
| Device class | 3 |
| Review time (calendar days) | 667 |
Official FDA database record · FDA AI-enabled device list
All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.