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The XLTEK Stimulator Probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots. The probes are sterile and are for single patient use only.

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XLTEK Clear Signal Adhesive Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephalograph (EEG) and Nerve potential signals. The electrodes are for single patient use only.

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The EMU40 Headbox is an electroencephalograph that works in conjunction with XLTEK NeuroWorks software {FDA 510(k) #K980214}. The EMU40 Headbox is used to acquire, digitize, store and transmit physiological signals (such as EEG, pulse and oximetry signals) for EEG studies in research and clinical environments. The EMU40 Headbox requires competent user input, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information.

The EMU40 Headbox is an electroencephalograph that works in conjunction with XLTEK NeuroWorks software {FDA 510(k) #K980214}. The EMU40 Headbox is used to acquire, digitize, store and transmit physiological signals (such as EEG, pulse and oximetry signals) for EEG studies in research and clinical environments.

The XLTEK NeuroPath is intended to stimulate and measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies. The XLTEK NeuroPath is intended to be used as an adjunct to and not a replacement for conventional electrodiagnostic measurements.

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XLTEK Clear Signal Sub-dermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and are for single patient use only.

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The XLTEK Connex Headbox works in conjunction with Excel Tech Sleep software. This Connex headbox is used to acquire and review sleep recordings (polysomnography) in research or clinical environments for: - Digital recording of high-level output signals (such as EEG, respiratory and oximetry . signals) from conventional polygraphic recorders, signal transducers or amplifiers. - Selection of recorded signal sections for on-screen review, annotation and marking of . sleen stages. - Computer-assisted event marking and quantitative analysis of EEG, respiratory and . oximetry signals. - Computer-assisted reporting of simple measures obtained from the recorded signals (such . as magnitude, time and frequency and simple statistical measures of marked events) The Connex is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intraoperative settings. The Connex requires competent user input, and its output must be reviewed and interpreted by trained polysomnographers or trained medical professionals who will exercise professional judgment in using this information. The Connex does not make any judgment of normality of the displayed signals or the result of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.

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The XLTEK TREX is intended to be used as an electroencephalograph: to acquire, display, store and archive electroencephalographic signals.

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The Protektor Stimulator is intended to be used for the intraoperative diagnosis of active dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

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The EMU128S is intended to be used as an electroencephalograph: to acquire, store, and archive electroencephalographic signals.

The EMU128S is a digital electroencephalograph.