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510(k) Data Aggregation

    K Number
    K150804
    Device Name
    QBioScan
    Manufacturer
    MEDEIA, INC.
    Date Cleared
    2015-10-19

    (207 days)

    Product Code
    GZO
    Regulation Number
    882.1540
    Why did this record match?
    Product Code :

    GZO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QBioScan is indicated for the measurement of galvanic skin response to aid in the assessment of the sudomotor function. The device is intended for use on the general adult population in medical clinics, healthcare practices and out-patient departments of hospitals.
    Device Description
    QBioScan™ is a galvanic skin response measurement device intended for the collection and display of galvanic skin response recorded by the device consists of the following components: - . an off-the-shelf computer with proprietary device software pre-installed - . a custom electronics box that houses the QBioScan circuitry - a USB cable to connect the electronics box to the computer . - reusable electrode lead cables . - reusable hand and foot electrodes and optional disposable forehead electrodes . - . an off-the-shelf printer (optional) The device allows for a evaluation of sweat gland function based on a measuring method where patients are in contact with surface electrodes (reusable stainless-steel plates and optional disposable electrodes) and are exposed to an incremental low voltage (under the 60601-1 standard safety limits). The device tests the electrochemical reaction between electrodes and the chloride ion released by the stimulated sweat glands. This active test method provides information and evidence of a sweat gland dysfunction that might otherwise not be detectable in a physiological examination. The Bioelectrical Conductance (BEC, in micro-Siemens, uS) representing galvanic skin response for the hands and feet are expressed as quantitative results along with an asymmetry value expressed as the percent difference between the BEC values of the right / left hands and the right / left feet. The device does not provide any direct diagnosis rather the device provides information to the physician for inclusion in their decision making process.
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    K Number
    K152216
    Device Name
    SudoC
    Manufacturer
    LD TECHNOLOGY LLC
    Date Cleared
    2015-09-24

    (48 days)

    Product Code
    GZO
    Regulation Number
    882.1540
    Why did this record match?
    Product Code :

    GZO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SudoC device is a medical device for the measurement of galvanic skin response related to the sweat glands. The SudoC provides values. It is the physician's responsibility to make proper judgments based on these numbers. The device is indicated for use in general adult population. Prescription Use: Federal law restricts this device to sale by or on the order of a physician.
    Device Description
    The SudoC is a programmable electro medical system including: - USB plug and play hardware device including an electronic box, 2 reusable cables to connect . the box to electrodes and 2 tactile electrodes placed on the sole of each foot. - Software installed on a computer. ● As a galvanic skin response measurement device, it measures the skin resistance (i.e., conductance).
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    K Number
    K141872
    Device Name
    SUDOSCAN
    Manufacturer
    IMPETO MEDICAL INC
    Date Cleared
    2014-11-21

    (133 days)

    Product Code
    GZO
    Regulation Number
    882.1540
    Why did this record match?
    Product Code :

    GZO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SUDOSCAN System is a medical device for the measurement of galvanic skin response to aid in the assessment of sudomotor function. SUDOSCAN is indicated for use in the general adult population.
    Device Description
    SUDOSCAN is based on two well-known principles, reverse iontophoresis and electrochemistry. SUDOSCAN collects physiological data by means of chronoamperometry and processes them with analysis software. SUDOSCAN devices use both technologies, coupled and complemented with exclusive software which analyzes cutaneous conductance data collected through the chronoamperometric measurements. The SUDOSCAN system is composed of: - analog acquisition electronic circuitry with low-noise front end - multiplexing control unit for selecting the appropriate acquisition channels - optically isolated USB interface controller - power converter - 4 electrodes placed on the feet and the hands - touch-screen computer running the proprietary SUDOSCAN software
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    K Number
    K131568
    Device Name
    SUDO PATH
    Manufacturer
    LD TECHNOLOGY LLC
    Date Cleared
    2013-06-28

    (29 days)

    Product Code
    GZO
    Regulation Number
    882.1540
    Why did this record match?
    Product Code :

    GZO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SudoPath is a Galvanic skin response measurement device. The SudoPath provides values. It is the physician's responsibility to make proper judgments based on these numbers. The device is indicated for use in general adult population Prescription Use: Federal law restricts this device to sale by or on the order of a physician.
    Device Description
    SudoPath is a programmable electro medical system including: USB plug and play hardware device including an electronic box, 2 reusable cables to connect the box to electrodes and 4 tactile electrodes placed on the sole of the feet and on the palm of the hands. Software installed on a computer. As a galvanic skin response measurement device, it measures the skin resistance (i.e., conductance).
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    K Number
    K111308
    Device Name
    ZYTO HAND CRADLE
    Manufacturer
    ZYTO TECHNOLOGIES, INC
    Date Cleared
    2011-08-30

    (112 days)

    Product Code
    GZO
    Regulation Number
    882.1540
    Why did this record match?
    Product Code :

    GZO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The measurement of Galvanic Skin Response
    Device Description
    The ZYTO Hand Cradle is a Galvanic Skin Response Measurement Device. The device is designed, owned, manufactured, and distributed by ZYTO Technologies, Inc. The device consists of electrical circuit boards encased in a plastic/metal case. The device is non-invasive and comes in contact with the patient via conductive contacts (the equivalent of a stylus and hand-mass) incorporated into one piece, using the same functionality as the predicate device. The device connects to a computer to supply data to an operator.
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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?
    Product Code :

    GZO

    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
    K100233
    Device Name
    SUDOSCAN
    Manufacturer
    IMPETO MEDICAL
    Date Cleared
    2010-06-14

    (139 days)

    Product Code
    GZO
    Regulation Number
    882.1540
    Why did this record match?
    Product Code :

    GZO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SudoScan system is a medical device for the measurement of galvanic skin responses.
    Device Description
    SUDOSCAN device is based on two well-known principles, reverse iontophoresis and electrochemistry. SUDOSCAN device collects physiological data by means of chronoamperometry and processes them with analysis software. SUDOSCAN device uses both technologies, coupled and complemented with exclusive software which analyzes cutaneous conductance data collected through the chronoamperometric measurements. SUDOSCAN device is composed of: - -> The analog acquisition electronic circuitry with low-noise front end - → The multiplexing control unit for selecting the appropriate acquisition channels - -> The signal formatting and processing capabilities - > The optically isolated USB interface controller - -> The power converter, - > The connection circuitry to 6 electrodes placed on the feet, the hands and the forehead of the patient. is integrated into a customized touch-screen Windows XP-based Industrialgrade personal computer running the proprietary SUDOSCAN acquisition control and analysis software also responsible for archiving measurements taken on all patients.
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    K Number
    K053004
    Device Name
    MSAS-VANTAGE
    Manufacturer
    BIOMERIDIAN, INT.
    Date Cleared
    2006-01-13

    (79 days)

    Product Code
    GZO
    Regulation Number
    882.1540
    Why did this record match?
    Product Code :

    GZO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MSAS -- Vantage intended use is for the measurement of Galvanic Skin Response.
    Device Description
    Not Found
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    K Number
    K032935
    Device Name
    EPI-SCAN, MODEL P 100
    Manufacturer
    EDX EPI-SCAN, INC.
    Date Cleared
    2003-11-20

    (59 days)

    Product Code
    GZO
    Regulation Number
    882.1540
    Why did this record match?
    Product Code :

    GZO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the measurement of galvanic skin response.
    Device Description
    The development of the Epi-Scan P100 has been based on the combined principles of instrumentation and the electrophysiological effects of innervation of the sweat glands. This provides a noninvasive, painless instrument system fore the quantitative measurement of Selective Tissue Conductance, which has been operationally defined as "…the relative ability of biological tissue to conduct a weak (DC) electrical signal, which is applied for a selected period of time to a selected, limited and restricted surface area of that tissue ... " and which shares those same neuroanatomic reflex pathways as other tests of sympathetic skin activity or regional perspiration levels.
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    K Number
    K023355
    Device Name
    ASYRA
    Manufacturer
    GALLOWAY TECHNOLOGIES, LLC
    Date Cleared
    2003-06-24

    (260 days)

    Product Code
    GZO
    Regulation Number
    882.1540
    Why did this record match?
    Product Code :

    GZO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Anyra's intended use is for the measurement of Galvanic Skin Response
    Device Description
    Galvanic Skin Response Device
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