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The Neurovision Medical Motion Sensor is intended to detect, monitor and/or record limb movements on a physiological recorder, in adult patient sleep disorder studies, in a clinical setting.

The Neurovision Medical Motion Sensor is a disposable, multipurpose piezo accelerometer sensor configured to be self-powered (by "watch" type battery), disposable, and capable of being read by a small signal electrophysiologic monitor.

The Neurovision Ink Printed Endotracheal Tube Electrode is intended for use during surgery and parasurgical care only, with any compatible monitoring system, for continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as for providing an open airway for patient ventilation.

The Neurovision Ink Printed Endotracheal Tube Electrode is an endotracheal tube with integrated electrodes for electromyographic (EMG) monitoring during surgery. The ET tube is made of a flexible PVC material with an inflatable low pressure cuff. The Neurovision Ink Printed Endotracheal Tube Electrode is provided as a sterile, single use disposable accessory that connects to a compatible EMG monitor to provide an open airway for patient ventilation during EMG neuromonitoring of the Recurrent Laryngel Nerve (RLN).

The Signal Gear Urethral Catheter Electrode is intended for mucosal surface stimulation/recording from the external urinary sphincter for use in conjunction with urodynamic evaluation of the patient.

The Signal Gear Urethral Catheter Electrode is a single patient use, disposable sterile device. It consists of an adhesive, highly flexible, polyurethane film substrate that wraps around the urethral (Foley) catheter. The conductive portion of the electrode is printed onto the polyurethane film substrate in a pattern that, when the electrode is wrapped around the catheter, leaves two conductive contact surfaces forming the two electrical contacts of the electrode. The remainder of the conductive pattern is overwrapped by an additional layer of polyurethane film during manufacture in order to insulate the traces. The conductive ink used is silver, with the exception of the two electrical contacts of the electrode, which have an additional printed layer of gold ink. Lead wires are attached that terminate in a safety connector that cannot be connected to an AC power outlet. The Electrode connects to the user's electrodiagnostic equipment. The electrode is to be used under the supervision of a physician. When the urethral catheter with the applied electrode is inserted in the human urethra, the exposed two electrical contacts of the electrode contact the mucosal lining of the urethra in the location of the external urinary sphincter muscle, and the end of the electrode with leadwire attachments are outside of the urethral meatus.

This device is a manual surgical instrument for performance of dissection and nerve stimulation input to living tissue concurrently.

The Stimulating Hemostat and other manual instruments are dissectors modified by insulation and application of a connecting pin for connection to nerve stimulation. The specific instruments cleared for this modification in this 510(k) are the following: - Scissors Hinge Hemostat, curved, fine - Box Hinge Hemostat, curved, fine - Scissors Hinge Hemostat, right angle - Mosquito Hemostat, curved, fine - Halsted Hemostat, curved - Crile Hemostat, curved - Kelly Hemostat, curved - Schnidt Hemostat, curved, fine - Gemini Hemostat, curved, fine - Petit Point Mixter, right angle - McCabe Dissector, curved, fine - Jacobson Mosquito, curved, fine - House Rosen Elevator, coarse - Sheehy "Weapon", Large (2.4 mm) - Probe, Ball tip - Suction Stimulator (Neurovision model)

The Neurovision Ink Printed Endotracheal Tube Electrode is intended for use during surgery and parasurgical care only, with any compatible monitoring system, for continuous EMG monitoring and assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation.

The Neurovision Ink Printed Endotracheal Tube Electrode is a sterile, single use disposable accessory that connects to a compatible EMG monitor to provide an open airway for patient ventilation and continuous EMG monitoring of the laryngeal musculature during surgery. The ET tube is made of a flexible PVC material with an inflatable low pressure cuff. The Neurovision Ink Printed Endotracheal Tube Electrode is intended for use with any compatible EMG monitoring system, for continuous EMG monitoring of the laryngeal musculature as well as providing an open airway for patient ventilation.

The Neurovision Nerve Locator Monitor is an electronic device consisting of a surgical nerve stimulator and an evoked EMG Monitor with integrated detecting or warning capability. The device is intended to assist the surgeon in locating motor nerves that are at risk in surgical procedures.

The Neurovision Nerve Locator Monitor Model NV006 is a single channel evoked EMG device for surgical nerve location and monitoring. The device operates exactly as the predicate model NV004. The stimulation range for the predicate device (Model NV004) as a proactive nerve locator is up to 5.0 mA of pulsed nerve stimulation. An accessory cable adds optional "high level" stimulation (Model NV006) ranging from 3.0 to 12 mA.

The Suction Stimulator Probe is a dedicated manual surgical instrument that allows the surgeon to clear secretions and test surgical tissue with nerve stimulation at the same time and with the same instrument. It is intended for use only by a licensed physician and in conjunction with the Neurovision SE (Nerveana) Nerve locator Monitor System.

The Suction Stimulator Probe is a disposable, single use, sterile instrument that combines concurrent suction and stimulation into one device for use during tissue dissection and nerve stimulation during surgery. The instrument consists of a stainless steel shaft, partially insulated with biocompatible PTFE and ending with a ball-tip suction. Proximal connectors attach the instrument to a nerve stimulator. A tapered type adapter attaches the device to a standard suction catheter and a finger-hole allows for adjusting the suction strength manually by the surgeon. The insulated shaft has a 2mm diameter and 2 length options of 13 or 26 cm. The ball tip feature reduces the current density of stimulation, allows stimulation along right angles, such as drill holes, and prevents bone chip clogging of the instrument.

The Paired Hydrogel Electrode is used for evoked electrophysiological monitoring in soft tissue surgeries were motor nerves are at risk.

The Paired Hydrogel Electrodes are a modification of the M203KEN electrode currently distributed as the Singlet and Triplet Hydrogel Electrodes by Neurovision Medical Products. The Paired Hydrogel Electrode is created by attaching two Singlet M203KEN electrodes by their lead wires to the same DIN plug (shorting the electrodes). The Paired version is designed to provide a single pole of electrophysiological monitoring across a surface too wide to be covered by a single electrode.

The Neurovision Nerve Locator/Monitor is an electronic device consisting of a surgical nerve stimulator and an evoked EMG monitor with integrated detecting and warning capability. This device is intended for use in surqical procedures where motor nerves are at risk to assist the surgeon in locating these nerves. This device is intended for use only by qualified, trained medical practitioners who perform operative surgery and who fully understand that this device is only an adjuvant to proper surgical technique and good surgical judgment. The EMGView software is an accessory to the Neurovision Nerve Locator/Monitor. When the dedicated USB output of the EMG unit is connected to a personal computer, the PC installed software provides status monitoring data, troubleshooting data, real-time EMG waveforms, and digital backup of all data obtained during clinical use of the device. The real-time display of EMG waveforms is intended to assist the surgeon with nerve integrity monitoring.

The EMGView Software is a Windows PC operating system software dedicated to viewing and documentation of the output of the Neurovision (Nerveäna) Nerve Locator/Monitor. The software is dedicated to the EMG device by a serial USB connection. The EMGView software is a read-only device and is thus incapable of modifying or controlling the Nerveäna Device.