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510(k) Data Aggregation

    K Number
    K103026
    Device Name
    ELECTRO SENSOR -BODY COMPOSITION
    Manufacturer
    L.D. TECHNOLOGY, LLC
    Date Cleared
    2011-03-29

    (168 days)

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

    L.D. TECHNOLOGY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Calculation and Historical Tracking of: - . Actual Resistance - Actual Reactance . - Actual Impedance - Actual Phase Angle (PA) . - Estimated Body Fat Mass (FM) ● - Estimated Fat Free Mass (FFM) - Estimated Total Body Water (TBW) . - Estimated Intra-Cellular Water (ICW) ● - Estimated Extra-Cellular Water (ECW) ● - Estimated Basal Metabolic Rate (BMR) . - Estimated Daily Energy Expenditure (DEE) . - Actual Body Mass Index (BMI) . The device is not intended for use for diagnosis. The actual resistance, reactance, impedance and phase angle have no clinical utility and are for calculation of body composition only. The data are stored in PC in the Backup system of the E.S-BC software. As regard to the estimated TWB , ICW and ECW , the device is intended for use on healthy subjects' over 12 years old and under 80 years old and non-Hispanic whites, non-Hispanic blacks and Mexican Americans in the US population . As regard to the estimated FM and FFM, the device is intended for use on healthy subjects over 19 years old and under 63 years old and Caucasian and Hispanic Americans in the US population. The device is for over-the-counter use
    Device Description
    The E.S- BC is a single frequency electrical bioimpedance 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), total body water (TWB) and fluid distribution: intracellular water, and extracellular water. It has a tetra-polar set of leads, which are attached to self- adhesive skin electrodes. The E.S- BC has two operating modes: Direct and Algorithm. Direct Mode measures and displays values for impedance (Z), phase (Ph), resistance (R) and reactance (Xc). Algorithm Mode displays estimates of fat-free mass (FFM) ,fat mass (FM), total body Water (TBW), intracellular water (ICW), and extracellular water (ECW), plus their percentages. The device computes these values using accepted peer reviewed published algorithms tailored to the patient type: general population, obese patients, or children.
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    K Number
    K102166
    Device Name
    ELECTRO INTERSTITIAL SCAN
    Manufacturer
    L.D. TECHNOLOGY, LLC
    Date Cleared
    2010-12-10

    (130 days)

    Product Code
    GZO
    Regulation Number
    882.1540
    Why did this record match?
    Applicant Name (Manufacturer) :

    L.D. TECHNOLOGY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EIS-GS (Electro Interstitial Scan-GS) is a medical device for the measurement of galvanic skin response. The device is not intended to be used for any diagnosis. The data are stored in the PC in the backup system of the EIS-GS software. The device is intended for use only in healthy adult subjects. The device is intended for use only in practitioner's office and clinical setting. Prescription Use Caution: Federal law restricts this device to sale by or on the order of a physician.
    Device Description
    The EIS-GS system is a programmable electro medical system including: USB plug and play hardware device including an electronic box, 6 disposable electrodes, reusable electrodes and reusable cables. Software installed on a computer. Protocol communication: USB port. Through the 6 tactile electrodes, a weak current with a very low frequency is sending alternatively between 2 electrodes with a sequence and the EIS-GS system is recording the electrical conductivity of 22 pathways of the human body. In accordance with the 21 CFR 882.1540, the EIS-GS system is a galvanic Skin response device that provides skin conductance measurements on the PC screen.
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    K Number
    K102442
    Device Name
    E.S.O. (ELECTRO SENSOR OXI)
    Manufacturer
    L.D. TECHNOLOGY, LLC
    Date Cleared
    2010-09-10

    (15 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    L.D. TECHNOLOGY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. - To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement. - To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analyses of the input of the heart rate variability. The mathematical analysis of Photoelectrical Plethysmography and HRV are not intended use for diagnosis. The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission. The data are stored in PC in the Backup system of the ESO software. The device is intended use only for adult subjects (> 20 years old) This Oximeter is intended to be used in spot-checking (5 minutes) The device is intended use in licensed practitioner's office This device is no intended to be used at home, in hospital or out-of-hospital transport The device is not intended use in support life and not for continuously monitoring The system will be use by practitioner.
    Device Description
    - USB plug and play hardware device including an electronic box and reusable Adult SpO2 probe - Software installed on a computer. Description of the features - Displays SpO2%, pulse rate value and vertical bar graph pulse amplitude. - Mathematical analysis of the pulse waveform (photoelectrical Plethysmograph' feature). - Mathematical analysis of the Heart Rate Variability (HRV 'feature).
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    K Number
    K083229
    Device Name
    E.S TECK ( ELECTRO SENSOR TECK)
    Manufacturer
    L.D. TECHNOLOGY, LLC
    Date Cleared
    2009-02-23

    (112 days)

    Product Code
    MWI, DPS, DQA, JOM
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    L.D. TECHNOLOGY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Each module has specific feature and intended use 1. Pulse Oximeter: To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement. 2. Heart rate variability (HRV) : To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analyses of the input of the heart rate variability. The mathematical analysis of Photoelectrical Plethysmography and HRV are not intended use for diagnosis. The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission. The data are stored in PC in the Backup system of the ES Teck software. The device is intended use only for adult subjects (> 20 years old) This Oximeter is intended to be used in spot-checking (2 minutes) The device is intended use in licensed practitioner's office This device is no intended to be used at home, in hospital or out-of-hospital transport The device is not intended use in support life and not for continuously monitoring The system will be use by licensed practitioner.
    Device Description
    The ES Teck System is a programmable electro medical system (PEMS) including: . USB plug and play hardware device including an electronic box , 3 disposable clectrodes, reusable Adult SpO2 probe and reusable cables Software installed on a computer. . E.S Teck system is a combination of 2 devices (or modules) with specific features controlled by unique software: > Pulse Oximeter displays SpO2%, pulse rate value and vertical bar graph pulse amplitude. The photoelectrical Plethysmograph' feature (PP) analyzes the pulse waveform provided by the oximeter. A HRV (Heart Rate Variability) evaluates the variation of the heart rate, both in the time domain (statistical methods) and in the frequency domain (spectral analysis). Each ORS complex is detected and the so-called normal (NN) or Rate-to-Rate (RR) intervals between adjacent QRS complexes are resulting from sinus node depolarization.
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