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510(k) Data Aggregation

    K Number
    K082254
    Device Name
    MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
    Manufacturer
    BODYSTAT LTD.
    Date Cleared
    2011-02-07

    (913 days)

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

    BODYSTAT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the purposes of performing a non-invasive BIA measurement on normal healthy human adults and children to determine their Body Composition status. The measurements include Body Mass Index (BMI), waist/hip ratio, tissue impedance at 5kHz and at 50kHz. These measurements are used to calculate the estimated levels of body fat, body lean and dry lean, total body water, and metabolic rates, Bodystat BODY MANAGER and WELLNESS SOFTWARE PROGRAMS are automatically included with this device. The Body Manager Program is designed for when a client returns to be tested in order to track their changes in body composition over a period of time. The Wellness Program is designed for first time assessments on subjects. The program's graphical presentations provide information on each of the specific measurements in an educational format.
    Device Description
    The Bodystat 1500MDD Body Composition Monitoring Unit is a light weight, handheld, batteryoperated device that uses bio-electrical impedance analysis (BIA) to measure the impedance of the flow of an electrical current through the body. The impedance of tissue is proportional to the amount of fluid in the tissue; water is low in fat tissues, thus fat tissue has a high impedance, and high in lean tissues, thus lean tissue has a low impedance. The subject's age, sex, height, waist measurement, and hip measurement are also used to calculate various values. In practice, a small constant current is passed between electrodes spanning the body and the voltage drop between electrodes provides a measure of impedance. Prediction equations, previously generated by correlating impedance measures against an independent estimate of TBW (total body water), may be used subsequently to convert a measured impedance to a corresponding estimate of TBW. Lean body mass is then calculated from this estimate using an assumed hydration fraction for lean tissue; Bodystat uses a proprietary regression equation for this calculation. Fat mass is calculated as the difference between body weight and lean body mass. A body composition analysis report is comprised of Body Fat, Lean Body Mass, Dry Lean Mass, Total Body Water, and Optimal Ranges. Metabolic rates, Waist/Hip Ratio, and BMI are also reported. In addition, raw values are shown for Impedance at 5 kHz and at 50 kHz. The Bodystat 1500MDD contains separate equations for children aged 6 - 17 years and for adults aged 18 - 70 years.
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    K Number
    K082255
    Device Name
    QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT
    Manufacturer
    BODYSTAT LTD.
    Date Cleared
    2011-02-07

    (913 days)

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

    BODYSTAT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the purposes of performing non-invasive bio-electrical impedance analysis (BIA) measurements on healthy human adults and children to determine their Body Composition status. Such measurements include Body Mass Index (BMI), waist/hip ratio, and tissue Impedance at 5, 50, 100 and 200 kHz. These measurements are used to calculate the estimated levels of extra-cellular water, intracellular water, total body water, body fat, body lean and dry lean, and metabolic rates. QuadScan 4000 for Windows Software Program is automatically included with the device.
    Device Description
    The OuadScan 4000 Body Composition & Fluid Monitoring Unit is a light weight, handheld, battery operated device that uses bio-electrical impedance analysis (BIA) to measure the impedance of the flow of an electrical current through the body; impedance is measured at four frequencies: 5, 50, 100, and 200 kHz. The impedance of tissue is proportional to the amount of fluid in the tissue: water is low in fat tissues, thus fat tissue has a high impedance, and lean tissue is high in water, thus lean tissue has a low impedance. The subject's age, sex, height, weight, waist measurement, and hip measurement are also used to calculate various values. In practice, a small constant current is passed between electrodes spanning the body and the voltage drop between electrodes provides a measure of impedance. Prediction equations, previously generated by correlating impedance measures against an independent estimate of TBW (total body water) and ECW (extra-cellular water), may be used subsequently to convert measured impedances to corresponding estimates of TBW and ECW. By deduction, ICW is estimated. By applying the unique Bodystat® equation, Body Fat, Lean Mass and Dry Lean Mass can be assessed. The QuadScan 4000 contains separate body composition equations for children 6 years to 17 years, and adults 18 - 70 years.
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    K Number
    K082253
    Device Name
    BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT
    Manufacturer
    BODYSTAT LTD.
    Date Cleared
    2008-11-25

    (109 days)

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

    BODYSTAT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the purposes of performing a non-invasive bio-impedance analysis (BIA) measurements on normal healthy human adults to determine their Body Composition status. This device measures bio-electrical impedance when a 50 kHz signal is applied at specific locations on the subject. From this and the subject's age, gender, weight, height, waist and hip circumferences (optional), the device calculates the following estimated values: fat%, fat weight, lean%, lean weight, total body water%, total body water, dry lean weight, basal metabolic rate, basal metabolic rate/body weight ratio, average requirement (EAR), and actual body mass index and waist/hip ratio. OPTIONAL ACCESSORIES: Bodystat (1) BODY MANAGER and (2) WELLNESS SOFTWARE PROGRAMS. The Body Manager Program is ideal when a client returns to be tested in order to track their changes in body composition over a period of time. The Wellness Program is ideal for first time assessments on subjects. The program's graphical presentations provide information on each of the specific measurements in an educational format.
    Device Description
    The Bodystat 1500 Body Composition Monitoring Unit is an impedance plethysmograph that uses bio-electrical impedance analysis (BIA) to measure the impedance of the flow of an electrical current through the body. The impedance of tissue is proportional to the amount of fluid in the tissue; water is low in fat tissues, thus fat tissue has a high impedance, and high in lean tissues, thus lean tissue has a high impedance. In practice, a small constant current is passed between electrodes spanning the body and the voltage drop between electrodes provides a measure of impedance. Prediction equations, previously generated by correlating impedance measures against an independent estimate of TBW (total body water), may be used subsequently to convert a measured impedance to a corresponding estimate of TB W. Lean body mass is then calculated from this estimate using an assumed hydration fraction for lean tissue; Bodystat uses a proprietary regression equation for this calculation. Fat mass is calculated as the difference between body weight and lean body mass.
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    K Number
    K002835
    Device Name
    BODYSTAT
    Manufacturer
    BODYSTAT LTD.
    Date Cleared
    2001-07-03

    (294 days)

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

    BODYSTAT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994242
    Device Name
    BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
    Manufacturer
    BODYSTAT LTD.
    Date Cleared
    2000-03-15

    (90 days)

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

    BODYSTAT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MEASUREMENT OF: ESTIMATED: Body FAT BODY LEAN+ DRY LEAN TOTAL BODY WATER METABOLIC RATES ACTUAL: BODY MASS INDEX (BMI) WAIST / HIP RATIO IMPEDANCE AT 50 kHZ
    Device Description
    Not Found
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    K Number
    K980971
    Device Name
    BODYSTAT DUALSCAN 2005
    Manufacturer
    BODYSTAT LTD.
    Date Cleared
    1998-06-11

    (87 days)

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

    BODYSTAT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ESTIMATED MEASUREMENT OF: FAT, LEAN, WATER, INTRA-CELLULAR WATER, EXTRA-CELLULAR WATER, TOTAL ESTIMATED WATER AND IMPEDANCE VALUES AT 50 KHZ
    Device Description
    Not Found
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    K Number
    K971554
    Device Name
    BODYSTAT
    Manufacturer
    BODYSTAT LTD.
    Date Cleared
    1997-11-26

    (210 days)

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

    BODYSTAT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MEASUREMENT OF ESTIMATED EXTRA-CELLULAR WATER; ESTIMATED INTRA-CELLULAR WATER. ESTIMATED TOTAL BODY WATER; AND
    Device Description
    Not Found
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