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    K Number
    K041491
    Device Name
    ZEWA MFM-007 BLOOD PRESSURE MONITOR
    Manufacturer
    ZEWA, INC.
    Date Cleared
    2004-09-20

    (108 days)

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

    ZEWA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Zewa® MFM-007 Blood Pressure Monitor is intended for use by adults with moderately active to inactive lifestyles for measuring the systolic and diastolic blood pressure, and pulse rate (heart rate) by using an inflated cuff which is wrapped around the upper arm.
    Device Description
    The Zewa® MFM-007 Blood Pressure Monitor measures the systolic and diastolic blood pressure, and pulse rate (heart rate) by use of an inflatable cuff that is wrapped around the upper arm, a LCD display, a semiconductor sensor, and internal air pump, a battery power source and keys for operation.
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    K Number
    K024077
    Device Name
    DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR
    Manufacturer
    ZEWA, INC.
    Date Cleared
    2003-03-10

    (90 days)

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

    ZEWA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Delwa-Star® WS-FM Blood Pressure and Body Fat Monitor is intended for use by adults with moderately active to inactive lifestyles for measuring the systolic and diastolic blood pressure, and pulse rate (heart rate) by using an inflated cuff which is wrapped around the wrist. The device is also intended to estimate body fat by bioelectrical impedance analysis.
    Device Description
    The Delwa-Star® WS-FM Blood Pressure and Body Fat Monitor uses bioelectrical impedance analysis, a well established technique, for body fat assessment. It measures the systolic and diastolic blood pressure, and pulse rate (heart rate) by use of an inflatable cuff that is wrapped around the wrist, a LCD display, a semiconductor sensor, and internal air pump, a battery power source and keys for operation.
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