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510(k) Data Aggregation

    K Number
    K092391
    Device Name
    MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED
    Date Cleared
    2010-04-01

    (239 days)

    Product Code
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONCORD MEDICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Concord Medical Products MobileAED, MobileALS, MobileAED+ and AdvantageAED products are designed for emergency treatment of cardiac arrest by trained personnel to terminate potentially fatal arrhythmias. The user assesses the patient's condition and confirms that the patient is unconscious, absence of a pulse or signs of circulation and has an absence of normal breathing prior to use of the device. When the patient is a child or infant, up to 8 years of age or up to 55 lbs (25Kg), the Concord Medical Pediatric Defibrillation Pad which attenuates the energy should be used. Therapy should not be delayed to determine the patient's exact age or weight. The Concord Medical Adult Pad should be used for patients over 8 years old and over 55 Ibs (25Kg). The MobileALS and MobileAED+ products are the MobileAED with an option to provide manual control for defibrillation for use by advanced cardiac life support (ALS) users. The rescuer may use the ECG monitoring mode cable feature to provide a non-diagnostic ECG rhythm display of a breathing or responsive patient regardless of age. Connection of the ECG monitoring mode cable disables the defibrillation feature and allows ECG analysis either in background or by pressing the analyze button. Contraindications for Use - Defibrillation Do not use the MobileAED for defibrillation when the patient; Is conscious; or Is breathing; or Has a detectable pulse or other signs of circulation
    Device Description
    The MobileAED is a Biphasic AED which is a portable battery operated semiautomatic low power DC defibrillator. The device's ECG analysis algorithm analyzes the patient's cardiac rhythm to determine if a shockable versus nonshockable ECG rhythm is present. The operator follows the device instructions and presses the shock button to deliver a defibrillation shock. The MobileAED and AdvantageAED product features include a Status Indicator, Graphic Display, Voice Messages, Buttons for Power and Shock, ECG algorithm analysis, Biphasic truncated exponential waveform, Lithium Manganese Dioxide Battery, and disposable Pads for defibrillation. The MobileALS manual control features include Energy selection button, Charge button, Analysis button, and Sync button
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