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FDA PRODUCT CODE · CLASS III

MVK — Wearable Automated External Defibrillator

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.

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
CV
— Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
pma: 3
0
RECALL ENTRIES

Recent clearances

P200037Kestra Medical Technologies, Inc. · pma2026-07-16
P010030Zoll Manufacturing Corporation · pma2026-05-15
P230022Element Science, Inc. · pma2026-03-04

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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