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510(k) Data Aggregation

    K Number
    K202108
    Device Name
    External Counterpulsation System, Soulaire
    Manufacturer
    Vamed Medical Instrument Co., Ltd.
    Date Cleared
    2020-08-28

    (29 days)

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

    Vamed Medical Instrument Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The External Counterpulsation System, Soulaire device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. In addition, it is intended for use in healthy patients to provide improvement in vasodilation, and increased blood flow. It is intended for use under the oversight of a healthcare professional.
    Device Description
    The External Counterpulsation System, Soulaire device has similar design to the External Counterpulsation System Model ECP-MC3. The Soulaire system is computer-controlled system that inflates and deflates three pairs of air cuffs in synchronization with the patient's cardiac cycle. The three pairs of cuffs are wrapped around the calves, lower thighs, and upper thighs/buttocks of the patients. As diastde begins, the cuffs inflate separately in sequence from the calves, to the lower thighs, to the upper thighs including the lower buttocks. This inflation sequence generates and impels a counter-pulsation wave, increasing diastolic blood pressure (diastolic augmentation), coronary perfusion pressure and coronary blood flow, and raising cardiac output. The start of inflation, deflation and cuff pressure can be adjusted by the operator. The system will deflate simultaneously before systole, this will reduce the heart's workload and resistance of blood vessel. Before ECP treatment, ECG electrodes and Finger Clip plethysmograph Sensor are placed on the patient. The ECG waveform is used to generate triggering signals for cuff inflation and deflation. The plethysmograph waveform is used to monitor the proper timing of the inflation cycle and to indicate the effect of ECP treatment on patient homodynamic.
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