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510(k) Data Aggregation

    K Number
    K080853
    Device Name
    DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM
    Manufacturer
    Date Cleared
    2009-02-20

    (331 days)

    Product Code
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENEXEL-SEIN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DUO-CARE blood glucose and blood pressure measurement system consists of a meter with wrist cuff and test strips. The system is intended for use in the quantitative measurement of glucose in whole blood taken from the fingertip. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes mellitus, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for use on neonates. Also the system measures systolic and diastolic blood pressure and pulse rate from adult's wrist in the home care environment. The device employs a wrist cuff and the oscillometric method of measurement. The system includes optional accessory software that is installed on the users' computers for data management purposes.
    Device Description
    DUO-CARE Genexel-Sein Blood Glucose & Pressure Monitor system combines the function of a blood glucose monitoring system and a blood pressure meter in one unit. Supplies with the meter are test strips, lancets, lancing device, storage case and control solution. The blood glucose monitoring system is turned on by strip insertion; Once the user confirms that the numerical code on the display, and strip bottle all match, a test strip is inserted into the meter and glucose testing can proceed. The user then supplies finger-tip or control solution to the strip and the meter starts the measurement, which is completed in 5 seconds. Genexel-Sein, Inc has provided instructions and illustrations explaining, that the blood drop will be pulled into the strip sample entry by capillary action until meter beeps and the result will be show on liquid crystal display ("LCD") after 5 seconds. Results are automatically stored in the meter's memory for tracking purposes. The capacity of memory is 150 blood glucose values and average value of past 14 days or 30 days. Control Solution is sold separately from the kit. DUO-CARE adopts the wrist type cuff for blood pressure meter part. The cuff and control unit are combined into a single wrist-mounted assembly. The user interface panel has power switch, mode switch, memory switch, for blood pressure meter part and LCD for displaying the systolic blood pressure, diastolic blood pressure, pulse rate, date and time. This device has the memory function that permits memory and display of the 60 most recent measurement results. User should wrap the pressure cuff around the wrist with the palm facing up and pushes the "Power" button. The cuff will with appropriate air pressure automatically. Pressurization is automatically governed. If the initial inflation pressure (180mmHg) is inadequate for measurement, i.e. lower that the patient's systolic pressure, the pump will automatically repressurize to a preset level (30 mmHg) above the initial level. Symbols in the LCD indicate pressurization status at all times. The air of cuff is automatically deflated during blood pressure measurement. No special training beyond basic ability to follow instruction is required. Since the products are designed for home use, detailed instructions on avoidance of practices that adversely affect the accuracy of measurements are included in the instruction manual.
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    K Number
    K071523
    Device Name
    FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, BP1650, BP1700 AND BP1750
    Manufacturer
    Date Cleared
    2007-06-26

    (22 days)

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

    GENEXEL-SEIN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To measure systolic and diastolic blood pressure and pulse rates of adults using wrist cuff and oscillometric method.
    Device Description
    Full Auto Wrist Blood Pressure Monitor (Models BP1600, BP1650, BP1700 and BP1750) is intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using wrist cuff and oscillometric method of measurement. The user interface panel of the device has power button, memory button and liquid crystal display ("LCD") for displaying systolic pressure, diastolic pressure and pulse rate. The device has memory capacity to store 10, 20, 60 and 90 most recent measurement results (respectively for BP1600, BP1650, BP1700 and BP1750). The device measures blood pressure through the use of an automatic inflating cuff. Pressurization is automatically governed. If the initial inflation pressure (180mmHg) is inadequate for measurement, i.e. Iower that the patient's systolic pressure, the pump will automatically re-pressurize to a preset level (30 mmHg) above the initial level. Symbols in the LCD indicate pressurization status at all times. The cuff automatically deflates with stepwise pressure drop of 5~6 mmHg per 2 pulses during blood pressure measurement.
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