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510(k) Data Aggregation

    K Number
    K110118
    Device Name
    STIMTRODE SINGLE USE NERVE STIMULATOR
    Manufacturer
    XAVANT TECHNOLOGY (PTY), LTD.
    Date Cleared
    2011-02-17

    (30 days)

    Product Code
    BXN, K11
    Regulation Number
    868.2775
    Why did this record match?
    Applicant Name (Manufacturer) :

    XAVANT TECHNOLOGY (PTY), LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stimtrode™ is intended to be used by an anesthetist during a peripheral nerve block procedure for nerve localization using invasive electrodes/needles (supplied separately).
    Device Description
    The Stimtrode device is a battery powered peripheral nerve stimulators that can be used for - · nerve locating using invasive electrodes/needs (not supplied) The stimulus is generated by a constant current source. The waveform is a square wave with 3 options for pulse width. These are: 0.1, 0.3 and 0.5 milliseconds. The units will continuously check for a closed circuit at 2Hz. Once a closed circuit is detected, the twitches will repeat at 2Hz, until an open circuit is detected. The unit is permanently attached to the anode. The anode comprises a modified ECG type pad. The cathode comprises of a nerve locating needle that is attached at time of use.
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    K Number
    K102084
    Device Name
    STIMPOD NMS450 NERVE STIMULATOR
    Manufacturer
    XAVANT TECHNOLOGY (PTY), LTD.
    Date Cleared
    2010-12-16

    (143 days)

    Product Code
    BXN
    Regulation Number
    868.2775
    Why did this record match?
    Applicant Name (Manufacturer) :

    XAVANT TECHNOLOGY (PTY), LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is a nerve stimulation device designed to be used by an anesthetist during 1. General Anaesthesia, for the purpose of establishing the efficacy of a Neuromuscular Blocking Agent using non-invasive surface electrodes (not supplied). 2. Regional Anaesthesia for the purpose of a. Nerve mapping using the non-invasive Nerve Mapping Probe (supplied). b. Nerve locating using invasive electrodes/needles (not supplied).
    Device Description
    The STIMPOD NMS450 is a battery powered peripheral nerve stimulators that can be used for - nerve mapping using the non-invasive Nerve Mapping Probe (supplied) - nerve locating using invasive electrodes/needles (not supplied) - general anesthesia, for the purpose of establishing the efficacy of a Neuromuscular Blocking Agent using non-invasive surface electrodes (not supplied) The stimulus is generated by a constant current source. The waveform is a square wave with various pulse width options. The anode comprises of an ECG electrode (not supplied). The cathode comprises of - a permanently attached nerve mapping probe (supplied) for nerve mapping, - and/or a separate nerve locating needle (not supplied) for nerve locating, - and/or another ECG electrode (not supplied) for NMBA monitoring, depending on the mode of the unit.
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    K Number
    K093591
    Device Name
    STIMPOD MODEL NMS-400 NERVE STIMULATOR
    Manufacturer
    XAVANT TECHNOLOGY (PTY), LTD.
    Date Cleared
    2009-12-03

    (14 days)

    Product Code
    BXN, BAT
    Regulation Number
    868.2775
    Why did this record match?
    Applicant Name (Manufacturer) :

    XAVANT TECHNOLOGY (PTY), LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is a nerve stimulation device designed to be used by an anesthetist during regional anesthesia for the purpose of 1. nerve mapping using the non-invasive Nerve Mapping Probe (supplied) and 2. nerve locating using invasive electrodes/neeldes (not supplied)
    Device Description
    The STIMPOD NMS400 is a battery powered peripheral nerve stimulators that can be used for - nerve mapping using the non-invasive Nerve Mapping Probe (supplied) - nerve locating using invasive electrodes/needles (not supplied) The stimulus is generated by a constant current source. The waveform is a square wave with various pulse width options. The anode comprises of an ECG electrode (not supplied). The cathode comprises a permanently attached nerve mapping probe (supplied), and/or a separate nerve locating needle (not supplied), depending on the mode of the unit.
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    K Number
    K072092
    Device Name
    XPOD/XMAP NERVE STIMULATOR
    Manufacturer
    XAVANT TECHNOLOGY (PTY), LTD.
    Date Cleared
    2007-11-15

    (108 days)

    Product Code
    BXN
    Regulation Number
    868.2775
    Why did this record match?
    Applicant Name (Manufacturer) :

    XAVANT TECHNOLOGY (PTY), LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XPOD/XMAP is a nerve stimulation device intended to be used by an anesthetist during regional anesthesia procedures wherever peripheral anesthesia is normally applied. The XMAP is intended for percutaneous nerve mapping using the non-invasive Nerve Mapping Probe (supplied). The XPOD is intended for nerve localization using invasive electrodes/neEdles (not supplied).
    Device Description
    The XPod/XMap devices are battery powered peripheral nerve stimulators that can be used for - nerve mapping using the non-invasive Nerve Mapping Probe (supplied) - nerve locating using invasive electrodes/needles (not supplied) The stimulus is generated by a constant current source. The waveform is a square wave with 2 options for pulse width. These are: 0.1 and 0.3 milliseconds. The units will continuously check for a closed circuit at 2Hz. Once a closed circuit is detected, the twitches will repeat at 2Hz, until an open circuit is detected. Visual feedback of the current amplitude as well as pulse-width is given by means of an LCD screen. The unit is permanently attached to the anode. The anode comprises a modified ECG type pad. The cathode comprises a permanently attached nerve mapping probe, in the XMap model, and a separate nerve locating needle in the XPod model.
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