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510(k) Data Aggregation

    K Number
    K081587
    Device Name
    KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530
    Date Cleared
    2008-10-24

    (141 days)

    Product Code
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    KRELL PRECISION (YANG ZHOU) CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The KRELL Weight & Body Fat Monitoring Scale is indicated to measure body weight and impedance and estimate the percentage of Body Fat and body water, Bones mass using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults and children (from age 10 and up) who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy.
    Device Description
    The patient steps on the scale device, where two electrodes are located. The patient must step on the electrodes with bare feet, with normal moisture. Through harmless current stimulation of 500 µA, at 50 kHz, the Krell Body Fat Analyzer calculates the body fat percentage. This calculation is done via the Bioelectrical Impedance Method. The current is passed through the body and the impedance of the body determines the body fat. The calculation is based upon electrical impedance, height, age. and gender. The calculation is performed via internal software, which uses the variables programmed in by the user. There are elements of this process that can produce erroneous readings, such as dry feet or improperprogrammed data. The User's Manual defines items which could cause erroneous readings.
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