PMA
P230022: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati
FDA PMA · Wearable automated external defibrillator · Element Science, Inc.
Key facts
| PMA number | P230022 |
|---|---|
| Trade name | Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati |
| Generic name | Wearable automated external defibrillator |
| Applicant | Element Science, Inc. |
| Owner/operator | Element Science, Inc. |
| Product code | MVK |
| Approval date | Apr 30, 2025 |
| Docket number | FDA-7380 |
| Notice date | Dec 29, 2025 |
| Establishment registration | 3027605722 |
| FEI number | 3027605722 |
At a glance
- 1–9 Supplements
- Mar 4, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: