BEUDAMED
    Product Code: MVK FDA class 3

    Wearable Automated External Defibrillator

    Unknown

    A Wearable Automated External Defibrillator (AED) is a device worn by patients at risk for sudden cardiac arrest that continuously monitors cardiac rhythm and automatically delivers a defibrillatory shock to treat ventricular fibrillation or tachycardia, intended for use in home or hospital settings as prescribed. It is classified as FDA Class 3, requiring PMA approval, and is a life-sustaining device. The product code is MVK and the device is not an implant.

    View on FDA
    510(k)s
    0
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    MVK
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    CV
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✓
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    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.

    FEI Numbers

    This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.