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510(k) Data Aggregation

    K Number
    K232089
    Device Name
    SOZO Pro
    Manufacturer
    ImpediMed Limited
    Date Cleared
    2023-10-17

    (96 days)

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

    ImpediMed Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SOZO Pro has the following uses: For adult human patients at risk of lymphedema: A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of lymphedema. The use of the device to obtain an L-Dex score is only indicated for patients who will have or who have had lymph nodes, from the axillary and/or pelvic regions, either removed, damaged or irradiated. The SOZO Pro is intended for adult patients living with heart failure. This device is intended for use, under the direction of a physician, for the monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data. 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 (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 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
    K230530
    Device Name
    SOZO Pro
    Manufacturer
    ImpediMed Limited
    Date Cleared
    2023-05-04

    (66 days)

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

    ImpediMed Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SOZO Pro has the following uses: For adult human patients at risk of lymphedema: A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of lymphedema. The use of the device to obtain an L-Dex score is only indicated for patients who will have or who have had lymph nodes, from the axillary and/or pelvic regions, either removed, damaged or imadiated.
    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
    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?
    Applicant Name (Manufacturer) :

    ImpediMed Limited

    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
    K203473
    Device Name
    SOZO
    Manufacturer
    ImpediMed Limited
    Date Cleared
    2021-04-19

    (145 days)

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

    ImpediMed Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SOZO Body Fluid Analyzer is intended for adult patients living with heart failure. This device is intended for use, under the direction of a physician, for the noninvasive monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data.
    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 ("MySOZO") managed on an external cloudhosted database. 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 energy (200uA RMS) to the body across 256 frequencies spaced from 3kHz to 1000kHz and measures the resulting voltage levels.
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    K Number
    K193410
    Device Name
    SOZO Body Fluid Analyzer
    Manufacturer
    ImpediMed Limited
    Date Cleared
    2020-10-02

    (298 days)

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

    ImpediMed Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SOZO Body Fluid Analyzer is intended for adult patients living with heart failure. This device is intended for use, under the direction of a physician, for the noninvasive monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data.
    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 ("MySOZO") managed on an external cloudhosted database. 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 energy (200µA RMS) to the body across 256 frequencies spaced logarithmically 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?
    Applicant Name (Manufacturer) :

    ImpediMed Limited

    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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    K Number
    K180126
    Device Name
    SOZO
    Manufacturer
    ImpediMed Limited
    Date Cleared
    2018-04-16

    (90 days)

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

    ImpediMed Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For adult human patients at risk of lymphedema: A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of lymphedema. The use of the device to obtain an L-Dex score is only indicated for patients who will have or who have had lymph nodes, from the axillary and/or pelvic regions, either removed, damaged or irradiated.
    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 energy (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 extracellular fluid impedance levels for left and right limbs, and present the impedance ratio as an L-Dex® score for the clinician to review. This score facilitates their clinical assessment of lymphedema in adult human patients.
    Ask a Question
    K Number
    K172507
    Device Name
    SOZO
    Manufacturer
    ImpediMed Limited
    Date Cleared
    2017-12-22

    (126 days)

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

    ImpediMed Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SOZO Fluid Status Monitor is intended for adult patients living with heart failure. This device is intended for use, under the direction of a physician, for the noninvasive monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data.
    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 measures small quantities of electrical energy (200uA RMS) across 256 frequencies, spaced logarithmically from 3kHz to 1000kHz. Established algorithms are used to analyze data and calculate extracellular fluid impedance levels for left and right sides of the body, and present the impedance levels for the clinician to review. These scores facilitate the clinician's monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.
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    K Number
    K172122
    Device Name
    SOZO
    Manufacturer
    ImpediMed Limited
    Date Cleared
    2017-08-11

    (29 days)

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

    ImpediMed Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of unilateral lymphedema of the arm and leg in women and the leg in men. The device is only indicated for patients who will have or who have had lymph nodes, from the axillary and pelvic regions, either removed, damaged or irradiated. SOZOhub PC software - a PC software package that is intended to be used only with the ImpediMed SOZO device for uploading data on to the PC from the SOZO device, processing and analyzing of bioimpedance measurements.
    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 measures small quantities of electrical energy (200ua RMS) across 256 frequencies, spaced logarithmically from 3kHz to 1000kHz. Established algorithms are used to analyze data and calculate extracellular fluid impedance levels for left and right limbs, and present the impedance ratio as an L-Dex® score for the clinician to review. This score facilitates their clinical assessment of unilateral lymphedema of the arm and leg in woman, and the leg in men.
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    K Number
    K130338
    Device Name
    IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS
    Manufacturer
    IMPEDIMED LIMITED
    Date Cleared
    2013-05-31

    (109 days)

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

    IMPEDIMED LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of unilateral lymphedema of the arm and leg in women and the leg in men. The device is only indicated for patients who will have or who have had lymph nodes, from the axillary and pelvic regions, either removed, damaged or irradiated. Lymphedema Analysis PC Software - an optional PC software package that is intended to be used only with the ImpediMed L-Dex U400 device for uploading data on to the PC from the L-Dex U400, processing and analyzing of bioimpedance measurements.
    Device Description
    The ImpediMed L-Dex U400 Extra Cellular Fluid Analysis device is a battery powered bioimpedance spectroscopy device operating in tetra-polar mode via a set of leads that are attached to self-adhesive skin electrodes by means of alligator clips. The subject device accurately measures current, voltage and phase angle, and cakulates three bioimpedance parameters: impedance (Z), resistance (R) and reactance (Xc). These measurements and calculations are used to estimate extracellular fluid ratios, and calculate the Lymphedema Index or L-Dex. The L-Dex U400 measures bioimpedance parameters over a frequency range of 4 - 1000 kHz with 256 data points. An on-screen graph displays the raw measured data in the form of a resistance vs. reactance complex impedance plot. These bioelectrical parameters are then used in algorithms to give an L-Dex value for the affected compared to the unaffected limb. Measured impedance ratios (L-Dex values) and normal ranges are shown on the device immediately after measurement and stored for later reference. Measured data may be transferred to the ImpediMed Impsoft database software. The Impsoft software adds extra functionality and ease of data management, including viewing patient histories and printing reports.
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