BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Wearable Automated External Defibrillator

    PMA: P230022 · Decision Apr 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Wearable Automated External Defibrillator
    Trade Name
    Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati
    PMA Number
    P230022
    Device Class
    FDA Class 3
    Product Code
    MVK
    Generic Name
    Wearable automated external defibrillator
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 30, 2025
    Date Received
    July 3, 2023
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) ("Jewel"), Jewel P-WCD Firmware, Device Accessories Skin Preparation Kit, Placement Accessory, Device Removal Kit, Optional Software Accessories ES Mobile Application, ES Cloud, ES Report Generator, ES Clinical Portal. The Jewel P-WCD is indicated for adult patients 18 years of age and older who are at risk for Sudden Cardiac Arrest, and either are not candidates for or refuse an Implantable Defibrillator.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MVK Wearable Automated External Defibrillator