# MVK · Wearable Automated External Defibrillator

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/CV-misc/MVK

## Overview

- **Product Code:** MVK
- **Device Name:** Wearable Automated External Defibrillator
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **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](https://fda.innolitics.com/submissions/CV/CV-misc/MVK/P230022.md) | Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati | Element Science, Inc. | Apr 30, 2025 | APPR |
| [P200037](https://fda.innolitics.com/submissions/CV/CV-misc/MVK/P200037.md) | ASSURE Wearable Cardioverter Defibrillator (WCD) System | Kestra Medical Technologies, Inc. | Jul 27, 2021 | APPR |
| [P010030](https://fda.innolitics.com/submissions/CV/CV-misc/MVK/P010030.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/CV/CV-misc/MVK](https://fda.innolitics.com/submissions/CV/CV-misc/MVK)

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