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510(k) Data Aggregation

    K Number
    K230531
    Device Name
    SOZO Pro
    Manufacturer
    ImpediMed Limited
    Date Cleared
    2023-05-04

    (66 days)

    Product Code
    QJB, DSB, MNW
    Regulation Number
    870.2770
    Why did this record match?
    Product Code :

    QJB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SOZO Pro may be used as an adjunct to existing methods by aiding clinicians who are using Subjective Global Assessment (SGA) tools to assess patients at risk of protein-calorie malnutrition (PCM). The SOZO Pro may be further used to estimate the following body composition parameters in humans to track clinically relevant body composition parameters over time: - · Fat mass - · Fat-free mass - Total body water - · Intracellular fluid - · Extracellular fluid - Skeletal muscle mass The following outputs are also presented: - · Body Mass Index (BMI) - · Basal metabolic rate (BMR; based on Mifflin St. Jeor's algorithm) displayed in calories per day • Protein and mineral (also known as 'dry lean mass') represents the content of a body that is not fat or fluid; calculated by subtracting total body water weight from fat-free mass weight. The SOZO Pro device measures current (1), voltage (V) and phase angle (Phi), and from these values calculates resistance (R). reactance (Xc), and impedance (Z), which are used to estimate the above body composition parameters. The device/ software will also display the Cole plot, subject height, weight, age and sex.
    Device Description
    The SOZO Pro system consists of a connected hand and footplate with built-in stainless-steel electrodes, paired with an Android tablet over Bluetooth connection. An app ("SOZOapp"), supplied with the tablet, controls the functionality of the hardware, and supplies the bioimpedance measurement data to a database ("MySOZO") managed on an external cloud- hosted database. Patient weight is measured with load cells located in the SOZO Pro foot unit or can be hand entered. Bioimpedance measurements require the patient's weight to be measured by a scale embedded in the base of the system or for the weight of the patient to be entered manually. Following the collection of the patient weight, the patient contacts the SOZO Pro with their bare hands and feet on stainless steel electrodes. The impedance measurement takes about 30 seconds, during which the SOZO Pro® system applies small levels of electrical energy (200µA RMS) to the body across 256 frequencies spaced from 3kHz to 1000kHz and measures the resulting voltage levels.
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    K Number
    K190529
    Device Name
    SOZO
    Manufacturer
    ImpediMed Limited
    Date Cleared
    2019-11-25

    (266 days)

    Product Code
    QJB, DSB, MNW
    Regulation Number
    870.2770
    Why did this record match?
    Product Code :

    QJB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SOZO system may be used as an adjunct to existing methods by aiding clinicians who are using Subjective Global Assessment (SGA) tools to assess patients at risk of protein-calorie malnutrition (PCM). The SOZO system may be further used to estimate the following body composition parameters in humans to track clinically relevant body composition parameters over time: - Fat mass - Fat-free mass - Total body water - Intracellular fluid - Extracellular fluid - Skeletal muscle mass The following outputs are also presented: - Body Mass Index (BMI) - Basal metabolic rate (BMR; based on Mifflin - St. Jeor's algorithm) displayed in calories per day - Protein and mineral (also known as 'dry lean mass') represents the content of a body that is not fat or fluid; calculated by subtracting total body water weight from fat-free mass weight. The SOZO device measures current (I), voltage (V) and phase angle (Phi), and from these values calculates resistance (R), reactance (Xc), and impedance (Z), which are used to estimate the above body composition parameters. The device/software will also display the Cole plot, subject height, weight, age and sex.
    Device Description
    The SOZO system consists of a connected hand and footplate with built-in stainless steel electrodes, paired with an Android tablet over Bluetooth connection. An app ("SOZOapp"), supplied with the tablet, controls the functionality of the hardware and supplies the bioimpedance measurement data to a database ("SOZOhub") contained within the hospital/facility network. Measurements require the patient to make contact with bare hands and feet on stainless steel electrodes. The measurement takes about 30 seconds, during which the SOZO® system applies small levels of electrical current (200µA RMS) to the body across 256 frequencies spaced logarithmically from 3kHz to 1000kHz and measures the resulting voltage levels. Established algorithms are used to analyze data and calculate various body composition parameters and present the outputs for the clinician to review.
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