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510(k) Data Aggregation

    K Number
    K090479
    Device Name
    TANITA BODY COMPOSITION ANALYZER, MODEL SC-331
    Manufacturer
    TANITA CORPORATION OF AMERICA
    Date Cleared
    2009-07-07

    (133 days)

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

    TANITA CORPORATION OF AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TANITA Body Composition Analyzer is indicated for use in the measurement of weight and impedance, and the estimation of body mass index (BMI), total body fat percent, total body water percent and weight, muscle mass (skeletal and smooth), physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI), metabolic age, and target body fat percent with predicted weight and fat mass, using BIA (Bioelectrical Impedance Analysis). The device is indicated for use for healthy children 5-17 years old and healthy adults with active, moderately active, to inactive lifestyles.
    Device Description
    The TANITA Body Composition Analyzer SC-331 is a composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body mass index (BMI), total body fat percent, total body water percent and weight, muscle (skeletal and smooth), physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI), metabolic age, and target body fat percent with predicted weight and fat mass for use by adults and children.
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    K Number
    K062652
    Device Name
    INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR
    Manufacturer
    TANITA CORPORATION OF AMERICA
    Date Cleared
    2006-12-28

    (112 days)

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

    TANITA CORPORATION OF AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TANITA Ironman Innerscan Body Composition Monitor measures body weight, impedance and estimates total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate(BMR), daily caloric intake(DCI) and metabolic age using BIA (Bioelectrical Impedance Analysis). The device is intended to be used by generally healthy children 7-17 years old and generally healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment. Actual measurements made by the BC-558 include weight and impedance. Based upon these measured values, values are calculated for: total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI) and metabolic age.
    Device Description
    The TANTA Ironman Innerscan Body Composition Monitor BC-558 are a computer-operated body composition analyzer that utilizes BlA (bigledrical impedance analysis) to determine body fat percent, muscle mass, bone weight, visceral fat rating, Basal Metabolic Rate (BMR), metabolism age, physique rating, daily calorie intake (DCI), body water percent and segmental fat percent.
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