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510(k) Data Aggregation

    K Number
    K080825
    Device Name
    IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400
    Manufacturer
    IMPEDIMED PTY LTD.
    Date Cleared
    2008-10-03

    (193 days)

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

    IMPEDIMED PTY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The L-Dex U400: A bioelectrical impedance analyzer/monitor utilizing impedance ratios that supports the measurement of extra cellular fluid volume differences between the arms to aid in the clinical assessment of unilateral lymphedema of the arm in women. This device is not intended to diagnose or predict lymphedema of an extremity. Lymphedema Analysis PC Software – an optional PC software package that is intended to be used only with the ImpediMed L-Dex U400 analyzer/monitor for uploading data on to the PC from the L-Dex U400. processing and analyzing of bioimpedance measurements.
    Device Description
    The L-Dex U400 is a multi frequency bioelectrical impedance analyser. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance as with the XCA. These measurements and calculations are used to estimate extra cellular fluid (ECF) allowing for the assessment of the development of unilateral Lymphedema of the arms. The ImpediMed L-Dex U400 Extra Cellular Fluid Analyzer, like the SFB7, is a battery powered, accurate, multi frequency, bioelectrical impedance analysis instrument operating in tetra-polar mode. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance.
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    K Number
    K050415
    Device Name
    IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS
    Manufacturer
    IMPEDIMED PTY LTD.
    Date Cleared
    2007-03-30

    (770 days)

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

    IMPEDIMED PTY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    (1) Imp XCA – A bioelectrical impedance analyzer/monitor utilizing impedance ratios that supports the measurement of extra cellular fluid volume differences between the arms to aid in the clinical assessment of unilateral lymphoedema of the arm. This device is not intended to diagnose or predict lymphoedema of an extremity. (2) Lymphoedema Analysis PC Software - an optional PC software package that is intended to be used only with the ImpediMed Imp XCA analyzer/monitor for uploading the data on to the PC from the Imp XCA via an infrared transfer for storing, processing and analyzing of bioimpedance measurements.
    Device Description
    The Imp XCA is a single frequency bioelectrical impedance analyser. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance. These measurements and calculations are used to estimate extracellular fluid (ECF) allowing for the clinical assessment of unilateral Lymphedema of the arm.
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    K Number
    K052319
    Device Name
    IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7
    Manufacturer
    IMPEDIMED PTY LTD.
    Date Cleared
    2006-04-04

    (222 days)

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

    IMPEDIMED PTY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    (1) Imp SFB7 – A bioelectrical impedance analyzer/monitor that is intended to estimate the following body composition parameters: Fat-free Mass (FFM), Fat Mass (FM), Total Body Water (TBW), Intra cellular Fluid (ICF), Extra cellular Fluid (ECF), and Body Mass Index (BMI). The device measures current, voltage 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-Cole plot, resistance vs. frequency plot, reactance vs. frequency plot, subject height, age and sex. (2) Biolmp Body Composition Analyzer PC Software: A PC software package that is intended to be used only with the ImpediMed Imp SFB7 Analyzer for uploading the MFBIA mode data on to the PC from Imp SFB7 via an Ethernet port for storing, processing and analysing of MFBIA bioimpedance measurements. This displays Cole-Cole plot, body composition parameters: Fatfree Mass (FFM), Fat Mass (FM), Total Body Water (TBW), Intra cellular Fluid (ICF), Extra cellular Fluid (ECF), Body Mass Index (BMI), and subject height, weight, age, sex, time, and date of measurement, Practitioner's name and Device serial number, and bioelectrical parameters resistance (R), reactance (Xc), and impedance (Z) and phase angle (Phi) at different frequencies (Between 4 kHz to 1000 kHz). The software can be used to generate patient body composition report displaying all the parameters stated above. These devices are intended to be used only on healthy patients, who wish to have their body composition estimated in the home or clinical environment.
    Device Description
    The Imp SFB7 is a multiple frequency bioelectrical impedance analyzer. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance. These measurements and calculations are used to estimate the body composition: fat-free mass (FFM) and fat mass (FM), and fluid distribution: total body water (TBW), intracellular fluid (ICF), and extracellular fluid (ECF). The device has 2 modes of operation 1. MFBIA Mode This is a Multiple Frequency Bioelectrical Impedance mode. Impedance readings are taken by applying all 256 frequencies sequentially in a very short time in the range of 4 kHz to 1000 kHz. 2. Selected Frequencies Mode - Any three user selected frequencies between 4 kHz to 1000 kHz and five pre set (5, 10, 50, 100, 500 kHz) frequencies are used to measure impedance of a subject. In MFBIA and Selected Frequencies mode, selection of single, continuous measurements or measurements at a selected interval of time is available. Over 1000 records can be stored and analyzed on Imp SFB7 or can be downloaded to a PC or laptop loaded with an optional Biolmp Body Composition Analysis software via an Ethernet connection. The ImpediMed Imp SFB7 Body Composition Analyzer is a rechargeable battery powered, accurate, portable, multiple frequency bioelectrical impedance analysis instrument operating in tetra-polar (4 leads - 2 current source and 2 voltage sensing) mode. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance. Bioimpedance analyzers calculate complex impedance or opposition to the flow of an electric current by the body. The applied electrical current travels through the extra cellular fluid of the body and through the lean muscle-organs via the intracellular fluid. Impedance is low in lean tissue, extra cellular fluid and intracellular fluid, where electrolytes are primarily contained, but high in fat tissue because fat is primarily an insulator containing very few conducting elements. Therefore impedance can be related to the total water volume of the body because the impedance is a direct measure of both intracellular and extra cellular fluid. In the Imp SFB7 a small constant current, typically 200 uA RMS, with in the frequency range of 4 kHz to 1000 kHz sequentially, is passed between two current electrodes spanning the body. The voltage drop measured between a second pair of voltage-sensing electrodes is used to calculate the complex impedance value. The calibration of the device may be checked with the aid of the supplied test cell. MFBIA Mode: Imp SFB7 in MFBIA mode works by calculating the complex impedance, applying all 256 frequencies (4 kHz to 1000 kHz) sequentially in a very short time to reduce the time to complete the test and the inconvenience to the subject. Impedance calculations made over a range of frequencies (4 kHz-1000 kHz) are used to create a Cole-Cole plot. Hanai modeling, which treats body as a concentrated suspension of cells in a conductive medium is used to estimate extracellular fluid (ECF) at low frequency and total body water (TBW) at high frequency. Intra cellular fluid (ICF) is then estimated by the difference between TBW and ECF. Fat free mass (FFM) is estimated from measured TBW assuming the hydration constant of a person as 73.2%. Fat mass (FM) is estimated from the difference between body mass and fat free mass. Selected Frequencies Mode: Imp SFB7 in Selected Frequencies mode has 5 pre set frequencies (5, 10, 50, 100, 500 kHz) and allows user to enter 3 frequencies of their choice in the range of 4 kHz to 1000 kHz to measure impedance of a subject. It measures, displays, and stores the impedance readings for these selected frequencies.
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    K Number
    K050395
    Device Name
    IMPEDIMED - BODY COMPOSITION ANALYSIS
    Manufacturer
    IMPEDIMED PTY LTD.
    Date Cleared
    2005-07-13

    (147 days)

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

    IMPEDIMED PTY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A body composition analyzer and a software package that will estimate display and store the following body composition parameters: Fat-free Mass (FFM), Fat Mass (FM), Total Body Water (TBW), Intra cellular Water (ICVV), I Fut noo Mass (ECW), Body Mass Index (BMI) and Basal Metabolic Rate (BMR). Extra octualiar vialer (2 x 77), voltage and phase angle (Phi), and from these values calculates The device moductions our only ready which are used to estimate the above body resistance (1), roustanto (1), roustanto (1), also display the user's height, weight, age, % oompoolion parameter of measurement, Practitioner's name and Device serial number. This device is intended for use on healthy children (9 - 16 years old), general and obese adult rubjects, only for body composition assessment in the home or clinical environment.
    Device Description
    The Imp DF50 is a single frequency bioelectrical impedance analyser. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance. These measurements and calculations are used to estimate the body composition: fat-free mass (FFM) and fat mass (FM), and fluid distribution: total body water, intracellular water, and extracellular water. The ImpediMed Imp DF50 Body Composition Analyzer is a battery powered, accurate, handheld, single frequency, bioelectrical impedance analysis instrument operating in tetra-polar mode. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance. Bioelectrical impedance analysis measures the impedance or opposition to the flow of an electric current through the body fluids contained mainly in the lean and fat tissue. Impedance is low in lean tissue, where intracellular fluid and electrolytes are primarily contained, but high in fat tissue. Impedance is thus related to total body water volume. In practice, a small constant current, typically 200 uA± 10uA peak-to-peak at a fixed frequency of 50 kHz± 100Hz is passed between two current electrodes spanning the body. The voltage drop measured between a second pair of voltage-sensing electrodes provides a measure of impedance. The performance of the device may be checked with the aid of a calibration circuit (supplied as an accessory) for quality assurance or servicing purposes. Prediction equations from peer reviewed journal articles, generated by correlating impedance measures against an independent estimate of Total Body Water (TBW), may be used to convert measured impedance to a corresponding estimate of TBW. Lean body mass is then calculated from this estimate using an assumed hydration for lean tissue. Fat mass is subsequently calculated as the difference between body weight and lean body mass.
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