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510(k) Data Aggregation

    K Number
    K112647
    Device Name
    BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM
    Date Cleared
    2011-11-22

    (71 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    WISTRON CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BestShape system is a system designed to measure blood pressure non-invasively. It is intended for use at home and in clinical settings. The measurement position of the device is the wrist of the subject. This system should be used for the testing on people over age of 18. The device is not to be used for the diagnosis or screening of hypertension or for testing on newborns
    Device Description
    The BestShape Blood Pressure Monitoring System uses the oscillometric method to measure the systolic, diastolic blood pressure and pulse rate with an inflatable wrist cuff on adults.
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    K Number
    K110770
    Device Name
    HEALTHTRACKER
    Date Cleared
    2011-11-16

    (243 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    WISTRON CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The HealthTracker is a software accessory for use with a blood pressure monitor with data transmission capabilities. This software is able to transfer data from the device's memory to a computer. The HealthTracker is intended for use at home and clinical settings as an aid for users and their healthcare professionals to review, analyze and manage the historical results. The HealthTracker is intended for use with BestShape Blood Pressure Monitoring System.
    Device Description
    The HealthTracker is an optional software accessory for use with a blood pressure monitoring system with data management capabilities. The HealthTracker transfers data from the device's memory to a computer for enhanced data management. The proposed software includes functions of managing personal account information on computer and data upload from blood pressure monitor to a personal computer or Health Vault. The HealthTracker is for use with BestShape Blood Pressure Monitoring System. The HealthTracker can control BestShape Blood Pressure Monitoring System in its recording of blood pressure measurements and transmitting of the data to a computer with the subject software.
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