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510(k) Data Aggregation

    K Number
    K033657
    Device Name
    MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V
    Manufacturer
    LIVING DATA TECHNOLOGIES CORPORATION
    Date Cleared
    2003-12-19

    (28 days)

    Product Code
    DRN
    Regulation Number
    870.5225
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIVING DATA TECHNOLOGIES CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mobile External Counter Pulsation System AngioNew-V is a mobile noninvasive external counter pulsation device for the treatment of patients suffering from congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction and cardiogenic shock.
    Device Description
    The Mobile External Counter Pulsation System AngioNew-V is a mobile noninvasive external counter pulsation device for the treatment of patients suffering from congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction and cardiogenic shock. The Living Data Technology AngioNew-V system consists of a central control unit and three pairs of inflatable cuffs that are wrapped respectively around a patient's calves, thighs and buttocks. External pressure is applied via the cuffs to the lower extremities of the patient in synchronization with the heartbeat. When the heart is in the relaxed state during diastolic period, pressure is applied sequentially from the distal to proximal extremities to force blood back to the heart, increase coronary perfusion pressure (diastolic augmentation) and, at the same time, increases coronary blood flow and enhances the development of coronary collateral circulation. Just before the heart starts ejecting blood during systolic period, air is quickly withdrawn from all cuffs simultaneously to remove all the external applied pressure, leaving behind empty vasculature in the lower extremities to receive the output of the heart, thereby reducing systolic pressure (systolic unloading) and the workload of the heart.
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    K Number
    K023701
    Device Name
    ANGIONEW-IV
    Manufacturer
    LIVING DATA TECHNOLOGIES CORPORATION
    Date Cleared
    2003-01-30

    (87 days)

    Product Code
    DRN
    Regulation Number
    870.5225
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIVING DATA TECHNOLOGIES CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mobile External Counter Pulsation System AngioNew-IV is a non-invasive external counter pulsation device intended for use in the treatment of patients with congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction or cardiogenic shock.
    Device Description
    The Mobile External Counter Pulsation System AngioNew-IV is a mobile noninvasive external counter pulsation device for the treatment of patients suffering from congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction and cardiogenic shock. The Living Data Technologies AngioNew-IV system consists of a central control unit and three pairs of inflatable/deflatable cuffs that are wrapped respectively around a patient's calves, thighs and buttocks. External pressure is applied via the cuffs to the lower extremities of the patient in synchronization with the heartbeat. When the heart is in the relaxed state during diatolic period, pressure is applied sequentially from calves to thighs and then to buttocks to force blood back to the hear, increase coronary perfusion pressure (diatolic and augmentation) and, at the same time, increases coronary blood flow and enchances the development of coronary collateral circulation. Just before the heart starts eiecting blood during systolic period, air is quickly withdrawn from all cuffs simultaneously to remove all the external applied pressure, leaving behind empty vasculature in the lower extremities to receive the output of the heart, thereby reducing systolic pressure (systolic unloading) and the workload of the heart.
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