MVK · Wearable Automated External Defibrillator
· Class 3
Overview
| Product Code | MVK |
|---|---|
| Device Name | Wearable Automated External Defibrillator |
| Device Class | Class 3 |
| Review Panel | |
| Life-Sustaining | Yes |
Identification
The device is an automatic external defibrillator which monitors and treats a patient for ventricular defibrillation. Device is intended to be worn in home or in hospital settings as prescribed and overseen by a physician.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P230022 | Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati | Element Science, Inc. | Apr 30, 2025 | APPR |
| P200037 | ASSURE Wearable Cardioverter Defibrillator (WCD) System | Kestra Medical Technologies, Inc. | Jul 27, 2021 | APPR |
| P010030 | WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST | Zoll Manufacturing Corporation | Dec 18, 2001 | APPR |
Top Applicants
- Element Science, Inc. — 1 clearance
- Kestra Medical Technologies, Inc. — 1 clearance
- Zoll Manufacturing Corporation — 1 clearance
