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510(k) Data Aggregation

    K Number
    K060848
    Device Name
    BOD POD
    Date Cleared
    2006-06-27

    (91 days)

    Product Code
    Regulation Number
    870.2770
    Why did this record match?
    Product Code :

    OAC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BOD POD® is indicated for measuring the body mass and estimating the body composition (i.e. percent and absolute amounts of fat and lean body mass) of generally healthy individuals. The BOD POD is also indicated for estimating Resting Metabolic Rate (RMR) and Total Energy Expenditure (TEE) in generally healthy individuals aged 18 years or older.
    Device Description
    The Sonamet Body Composition System is designed to measure the mass and estimate the body composition of individuals. Once an individual's body composition has been determined, the BOD POD is able to accurately estimate Resting Metabolic Rate (RMR) and total Energy Expenditure (TEE). The BOD POD estimates body composition using a densiometric approach (i.e. by determining the density of the entire body). A weighing apparatus is used to measure the subject's mass. Air displacement plethysmography is used to measure the subject's volume. Using this data, the subject's density is calculated. The subject's body composition is then estimated using several algorithms derived from scientific research. An individual's RMR and TEE can also be estimated accurately using values for Fat Mass and Fat Free Mass. Scientifically derived algorithms utilize the Fat Mass and Fat Free mass values determined by the BOD POD to calculate RMR and TEE.
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    K Number
    K032610
    Device Name
    MODIFIED SONAMET BODY COMPOSITION ANALYZER
    Date Cleared
    2004-03-01

    (189 days)

    Product Code
    Regulation Number
    870.2770
    Why did this record match?
    Product Code :

    OAC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The modified Sonamet Body Composition Analyzer, also known as the PEA POD® Infant Body Composition System (the PEA POD), is indicated for measuring body mass and estimating the body composition (i.e., the body fat and lean body mass) of infants between 1 and 8 kilograms. It is not intended for use with infants requiring life support.
    Device Description
    The modified Sonamet Body Composition System ("The PEA POD") is designed to measure the mass and estimate the body composition of infants with body weights ranging between 1 and 8 kilograms, who do not require life support. The PEA POD estimates body composition using a densiometric approach (i.e. by determining the density of the entire body). A weighing apparatus is used to-measure the subject's mass. Air displacement plethysmography is used to measure the subject's volume. Using this data, the subject's density is calculated. The - subject's body composition is then estimated using several algorithms derived from scientific research. The device components are housed in a movable cart, which contains the reference chamber, calibration volume, air circulation system, Air Temperature Control System, electronic components, printer and CPU.
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