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510(k) Data Aggregation

    K Number
    K083838
    Device Name
    SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES
    Manufacturer
    FOOK TIN TECHNOLOGIES LIMITED
    Date Cleared
    2009-05-12

    (140 days)

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

    FOOK TIN TECHNOLOGIES LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scaleman Body Fat Scales - Models in "Family Model List 1A" is a series of body composition analyzers that measure body weight and impedance and estimate percentage of body fat and body water using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment. The Scaleman Body Fat Scales - Models in "Family Model List 1B" is a series of body composition analyzers that measure body weight and impedance and estimate percentage of body fat and body water, bone mass and muscle mass using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.
    Device Description
    Body composition analyzer/scale that utilizes a “foot-to-foot” bioelectrical impedance (BIA) technology to determine internal body composition.
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