BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated External Defibrillators (Non-Wearable)

    PMA: P160033 · Decision Dec 7, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66

    Basic Information

    Device Name
    Automated External Defibrillators (Non-Wearable)
    Trade Name
    Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3
    PMA Number
    P160033
    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
    December 7, 2018
    Date Received
    August 3, 2016
    Expedited Review
    N
    Docket Number
    18M-4675

    Advisory Committee Statement

    Approval for the Powerheart® AED G3, Powerheart® AED G3 Plus, and the Powerheart® AED G5.The Powerheart® AED G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are:1) unresponsive;2) not breathing normally; and3) without pulse.When the patient is a child or infant up to 8 years of age, or up to 55 lbs. (25kg), the device should be used with the Intellisense Defibrillation Pad Pediatric. The therapy should not be delayed to determine the patient's exact age or weight.The Powerheart® AED G3 is intended to be used by personnel who have been trained in its operation.The Powerheart® AED G3 Plus is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are:1) unresponsive;2) not breathing normally; and3) without pulse.When the patient is a child or infant up to 8 years of age, or up to 55 lbs. (25kg), the device should be used with the Intellisense Defibrillation Pad Pediatric. The therapy should not be delayed to determine the patient's exact age or weight.The Powerheart® AED G3 Plus is intended to be used by personnel who have been trained in its operation.The Powerheart® AED G5 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are:1) unresponsive;2) not breathing normally; and3) without pulse.When a patient is a child up to 8 years of age, or up to 25kg (55 lbs.), the AED should be used with the Intellisense Defibrillation Pad Pediatric. The therapy should not be delayed to determine the patient's exact age or weight.The G5 Automated External Defibrillator (AED) is intended to be used by persons who have been trained in its operation.When used with the optional Intellisense Defibrillation Pad ICPR, the device offers CPR performance feedback to aid a trained rescuer by providing compression rate and depth performance feedback through audio prompting. The Intellisense Defibrillation Pad ICPR is indicated-for use on cardiac arrest patients 8 years of age or older, or who weigh more than 25 kg (55 lbs.).

    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)