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510(k) Data Aggregation

    K Number
    K121527
    Device Name
    WI-FI BODY SCALE
    Date Cleared
    2012-06-28

    (36 days)

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

    SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Wi-Fi body scale, model HS5 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass, bones mass, visceral fat rating and daily calorie intake (DCI) using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults,,who are not ill, feverish, have a chronic or acute disease, or a condition that affect the level of hydration such as pregnancy.
    Device Description
    The patient steps on the scale device, where four electrodes are located. The patient must step on the electrodes with bare feet, with normal moisture. Through harmless current stimulation of 500 uA, at 50 kHz, the Wi-Fi body scale 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, weight, age, and gender. The calculation is performed via internal software, which uses the variables programmed in by the user. Wi-Fi body scale, model HS5 can be used with an iPod Touch, iPhone or iPad.
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    K Number
    K112951
    Device Name
    BODY ANALYSIS SCALE
    Date Cleared
    2011-11-01

    (28 days)

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

    SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Body analysis scale, Model BF 66 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass, bones mass, visceral fat rating and daily calorie intake (DCI) using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults 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
    Not Found
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    K Number
    K110928
    Device Name
    BODY ANALYSIS SCALE, MODEL BG 17
    Date Cleared
    2011-07-15

    (102 days)

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

    SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Shenzhen Healthcare Electronic Technology Body analysis scale, Model BG 17 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass, bones mass, visceral fat rating and daily calorie intake (DCI) using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults 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 four 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 Shenzhen Healthcare Body Analysis scale 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, weight, 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 improper-programmed data. The User's Manual defines items which could cause erroneous readings.
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