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This device is a nerve stimulation device designed to be used by an anesthetist during: 1. General anesthesia, for the purpose of establishing the efficacy of a Neuromuscular Blocking Agent using non-invasive surface electrodes. 2. Regional anesthesia, for the purpose of: i. nerve mapping using the non-invasive Nerve Mapping Probe (supplied) ii. nerve locating using invasive needles (not supplied)

The STIMPOD NMS450 is a quantitative Neuromuscular Transmission (NMT) Monitor which provides real-time quantitative feedback utilizing tri-axial accelerometery. The STIMPOD NMS450 is also a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle through which local anaesthetics can be injected. The distance of the needle (cathode) from the nerve can be estimated by establishing the minimum threshold current required, to facilitate a neuromuscular response. The STIMPOD NMS450 currently makes use of 3 dimensional acceleromyography (AMG) as the measurement technology of choice for objective Neuromuscular Transmission (NMT) monitoring in surgery. Although AMG is still the de-facto standard in industry, the use of electromyography (EMG) has gained renewed interest in NMT monitoring applications where the introduction of robotic surgeries, new surgical techniques, and changes in workflow, for instance, made the use of AMG impracticable. In order to address this steadily increasing market demand for EMG sensor technology in NMT monitoring applications, Xavant identified the need to design and develop a dedicated NMT Monitoring Cable (EMG) that could be used interchangeably with the existing NMT Monitoring Cable (AMG) already in use with the STIMPOD NMS450. The NMT Monitoring Cable (EMG) was specifically designed for use with the STIMPOD NMS450 to assist anaesthesiologists in theatre with monitoring the efficacy of Neuromuscular Blocking Agents (NMBAs). The NMT Monitoring Cable (EMG) was designed with an intelligent EMG signal processing module (henceforth referred to as the µEMG) on one end of the cable for connection to an EMG electrode, and with a standard FireWire connector on the other end for connection to the STIMPOD NMS450.

Pajunk's MultiStim ECO is intended for nerve stimulation during anaesthesia delivery; first for identification of peripheral nerves and second for localizations. This device is indicated for adults only.

PAJUNK® GmbH Medizintechnologie is submitting this 510(k) for the MultiStim ECO handheld, battery powered peripheral nerve stimulator. The MultiStim ECO is a nerve stimulator that is suitable for stimulation technique. It is characterized in particular by the following properties: - small, compact device complies with the requirements of combined procedures - - -Simple operation - manual settings are limited to the parameters proven in practice - -No additional patient cable - cannula is directly connected to the device The MultiStim ECO settings are adapted to standard applications as well as the intuitively operated keyboard enable one-hand operation. A keystroke is all that is necessary for activation after switching on - an additional function selection is not required. Basic functions/ features: Fixed defined settings: The frequency is predefined at 1 Hz and the stimulation pulse width at 0.1 ms. Due to safety reasons, stimulation is first activated by a touch of the stimulation button. Variation of the current strength Depending on the special requirements of an application, the current strength can be gradually set on a six-level amplitude scale from 0.2 to 2.0 mA. Arrow buttons are used for the plus/minus key. Fixation by an adhesive electrode The MultiStim ECO has a pushbutton connection on the lower side of the device and is clicked directly on the adhesive electrode. The stimulateable cannula is connected directly to the MultiStim ECO.

SunStim Peripheral Nerve Stimulator and SunStim Plus Peripheral Nerve Stimulator are a battery-powered device intended for monitoring the magnitude of neuromuscular block in general anesthesia, by delivering an electrical stimulus near a peripheral motor nerve.

SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator are battery powered peripheral nerve stimulators which provide low electrical direct current (DC) stimulation in order to determine the level of anesthetic nerve block. The Stimulus Amplitude control dial provides variable current control (0 to 70 mA into a 2K ohm load). The Output Stimulus Pulse Indicator flashes each time current passes through the patient. Functions include: Double Burst (DBS), Train-of-Four, Twitch, and 100Hz Tetanus. The device offers sufficient output to ensure supramaximal stimulation: from 0 to 70 mA. SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator models have the same functions with the following exceptions: the SunStim™ Peripheral Nerve Stimulator functions do not include Double Burst and the 50 Hz Tetanus option.

The MiniStim* MS-IVB is a battery powered Peripheral Nerve Stimulator for monitoring the effects of skeletal muscle relaxants.

The MS-IVB is a nerve stimulator with selectable stimulus output waveforms and adjustable output amplitude. The stimulus output is intended for monitoring the depth of patient muscle and nerve relaxation while

The STIMPOD ST2-3010 is a nerve stimulation device designed to be used for the purpose of nerve locating using invasive electrodes or needles (not supplied)

The STIMPOD ST2-3010 device is a battery powered peripheral nerve stimulator that can be used for the purpose of nerve locating using invasive electrodes or needles (not supplied). The STIMPOD ST2-3010 is a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle. The stimulus is generated by a constant current source. The waveform is a monophasic square wave with 3 options for pulse width. These are: 0.1, 0.2 and 0.3 milliseconds. The unit dimensions are 145mm x 90mm x 30mm with a weight of 130 g

The EasyMed InstrumentsCo., LTD. Peripheral Nerve Stimulator is a battery -powered device intended for monitoring the magnitude of neuromuscular blocks in general anesthesia; by delivering an electrical stimulus near a peripheral motor nerve.

The EasyMed Peripheral Nerve Stimulator devices are battery powered peripheral nerve stimulators which provide low electrical direct current (DC) stimulation in order to determine the level of anesthetic nerve block. The Stimulus Amplitude control dial provides variable current control (0 to 70 mA into a 2K ohm load). The Output Stimulus Pulse Indicator flashes each time current passes through the patient. Functions include: Train-of-Four, Twitch, and 100Hz Tetanus. The device offers sufficient output to ensure supramaximal stimulation: from 0 to 70 mA. All finished products are tested and must meet all required release specifications before distribution. Testing includes physical testing (e.g. Pulse Amplitude, Pulse Width, Pulse Frequency and Low Battery Voltage Indicator) and visual examination.

The Intronix Model 8008 Myoguide System (Myoguide) is a medical device intended as a stimulator for nerve localization as well as an aid for guidance of injections into the muscles.

Myoguide is a battery powered, handheld, EMG amplifier with audio feedback, LCD EMG signal and device status display, and current stimulation ranging from 0 mA - 20 mA. This device is internally powered and rated for continuous use. The patient input connection is a type BF applied part. Myoguide will automatically power off after 30 minutes of inactivity to conserve battery life. Myoguide is designed to amplify electrophysiological signals from muscle and provide audio feedback to assist clinicians in locating areas of muscle activity. The Stimulator can be used as an adjunct. Myoguide provides muscle and nerve localization information, to accurately guide and monitor needle electrode insertion, and/or injection of neuromodulator drugs, into a muscle in the human body. Any drug used will be that of the physician. The large LCD display provides the complete system status at a glance. EMG audio, EMG signal display, EMG RMS Value, Integrated EMG signal strength and stimulation capability, increases efficacy for injection point localization. The simple control panel is intuitive and easy to operate. Myoguide operates in two modes: "[EMG]" and "[Stimulation]". The default mode, "[EMG]", records electromyographic (EMG) signals from electrodes placed on the subject. The second mode, "[Stimulation]", enables Myoguide's onboard stimulator to stimulate through the needle electrode that was used to record the EMG. This enables the clinician to record and stimulate through the same needle electrode. The <Mode> switch is used to change the state of operation.

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).

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.

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).

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.

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)

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.