BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated External Defibrillators (Non-Wearable)

    PMA: P200007 · Decision Jun 23, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66

    Basic Information

    Device Name
    Automated External Defibrillators (Non-Wearable)
    Trade Name
    HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads
    PMA Number
    P200007
    Device Class
    FDA Class 3
    Product Code
    MKJ
    Generic Name
    Automated external defibrillators (non-wearable)
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 23, 2023
    Date Received
    February 3, 2020
    Expedited Review
    N
    Docket Number
    23M-3187

    Advisory Committee Statement

    Approval for the HeartSync Multifunctional Defibrillation Electrodes. These devices are indicated for:For Automatic External Defibrillators: (Compatible Model AEDs: Physio Control: LifePak-15, LifePak-20/20e, LifePak -1000; Zoll Medical: R-Series, X-Series; Cardiac Science: PowerHeart AED G3 Plus, PowerHeart AED G3 Pro).When used with an external defibrillator, these electrode pads are for treating patients in cardiopulmonary arrest who are: 1) Unconscious; 2) Not breathing spontaneously; and 3) Without circulation (without a pulse). The pads are single use and intended to be used in conjunction with an external defibrillator to monitor and deliver defibrillation energy to the patient. The pads are used on patients over 8 years of age or greater than 55 pounds. The pads are intended for short term use (less than 8 hours). DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT. For Manual Defibrillators: Manual Defibrillators can be used for monitoring, pacing, cardioversion, as well as defibrillation. When used for defibrillation, these electrode pads are for treating patients in cardiopulmonary arrest who are: 1) Unconscious; 2) Not breathing spontaneously; and 3) Without circulation (without a pulse). The pads are single use and intended to be used in conjunction with an external defibrillator to monitor and deliver defibrillation energy to the patient. The pads are used on patients greater than 10 kg or 22 pounds. The pads are intended for short term use (less than 24 hours).DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT.

    Classifications

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

    Product Code Device Name
    MKJ Automated External Defibrillators (Non-Wearable)