Home › Device types › MVK
Wearable Automated External Defibrillator
FDA product code MVK · Class 3 · Unknown
52
Registered devices
150,940
Adverse events
5
Recalls
0
510(k) clearances
Devices with this code
ASSURE, Monitor — Kestra Medical Technologies, Inc.ASSURE, Carry Pack — Kestra Medical Technologies, Inc.LifeVest Wearable Defibrillator — ZOLL MANUFACTURING CORPORATIONASSURE, Garment, Style B, Size 7 — Kestra Medical Technologies, Inc.LifeVest Wearable Defibrillator — ZOLL MANUFACTURING CORPORATIONASSURE, Therapy Cable — Kestra Medical Technologies, Inc.Jewel Mobile App — Element Science, Inc.Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) ("Jewel") — Element Science, Inc.LifeVest Wearable Defibrillator — ZOLL MANUFACTURING CORPORATIONHospital Wearable Defibrillator — ZOLL MANUFACTURING CORPORATIONASSURE, Garment, Style B, Size 3 — Kestra Medical Technologies, Inc.Hospital Wearable Defibrillator — ZOLL MANUFACTURING CORPORATIONASSURE, Tablet — Kestra Medical Technologies, Inc.LifeVest Wearable Defibrillator — ZOLL MANUFACTURING CORPORATIONLifeVest Wearable Defibrillator — ZOLL MANUFACTURING CORPORATIONLifeVest Wearable Defibrillator — ZOLL MANUFACTURING CORPORATIONLifeVest Wearable Defibrillator — ZOLL MANUFACTURING CORPORATIONASSURE, Garment, Style A, Size 2 — Kestra Medical Technologies, Inc.ASSURE, Charger — Kestra Medical Technologies, Inc.LifeVest Wearable Defibrillator — ZOLL MANUFACTURING CORPORATIONJewel Starter Kit — Element Science, Inc.LifeVest Wearable Defibrillator — ZOLL MANUFACTURING CORPORATIONASSURE, Garment, Style A, Size 7 — Kestra Medical Technologies, Inc.LifeVest Wearable Defibrillator — ZOLL MANUFACTURING CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-09-12 | Zoll Manufacturing Corp. | Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure |
| 2010-09-24 | Zoll Lifecor Corporation | The response button function may become intermittent. This can result in the device not progressing beyond the response button test during startup, which may p |
| 2008-10-21 | Zoll Lifecor Corporation | The charging circuit will not shut down properly. |
| 2007-09-14 | Zoll Lifecor Corporation | Possible malfunction of the battery pack. A significant electrostatic discharge (ESD) can cause the battery pack to malfunction. The malfunction causes the bat |
| 2007-04-27 | Zoll Lifecor Corporation | The electrodes do not properly release conductive gel |
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