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The Natus VikingQuest is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG). Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP) , Electroretinography (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The Natus VikingQuest may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The VikingQuest is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition. The listed modalities do include overlap in functionality. In general. Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System. The Natus VikingQuest is intended to be used by a qualified healthcare provider.

The Natus VikingQuest is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform nerve conduction studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing, and intra-operative monitoring (IOM). VikingQuest provides a variety of tests spanning the various modalities. There are two configurations, portable and cart-based.

ViMove2 is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.

ViMove2 is a wireless electronic device used by healthcare professionals to accurately measure, record and analyze movement and muscle activity of the lower back. The device obiectively measures, records and analyzes angular movement and muscle activity. Under the direction of the healthcare professional, the software quides the patient through a series of dynamic movements and static postures in standing and sitting positions. ViMove2 then measures the range of motion and muscle activity, streams the data live via BTLE to a host device, e.g. PC, tablet or smart phone, and generates a personalized assessment report including comparisons to normative values. ViMove2 is comprised of the following key components: - · 4 Wireless Sensors (2 movement and 2 muscle activity) - · Disposable Application Pads for attaching sensors to the patient. - · ViMove software package

Cadwell Sierra Summit: Cadwell Sierra Summit is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), Evoked Potentials (EP), and Autonomic Reponses (RR Interval Variability). The Cadwell Sierra Summit is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions. The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. The interface for third-party non-invasive imaging display and control is used to visualize the morphology and location of nerves and serves as an aid in confirming the results of the aforementioned modalities. Cadwell Sierra Summit is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user. Cadwell Sierra Ascent: Cadwell Sierra Ascent is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), and Somatosensory Evoked Potentials (SEP). The Cadwell Sierra Ascent is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions. The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. Cadwell Sierra Ascent is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.

The Cadwell Sierra Summit and Ascent systems are designed for the acquisition, display, analysis, storage, and reporting of electrophysiologic information from the human nervous and muscular systems. The systems are designed to perform nerve conduction studies (NCS), needle electromyography (EMG) studies and evoked potential (EP) studies. The Sierra Summit is the full featured version and also includes autonomic (RR Interval) studies and an interface to allow display and control of non-invasive third-party imaging modalities.. Hereafter, the Sierra Summit is described as the full featured variant. The Summary of Technical Characteristics table below details the differences between the Summit and Ascent systems. The Sierra Summit provides a variety of test protocols spanning the various test modalities above. The Cadwell Sierra Summit consists of the following major components: - Sierra Summit console base unit with integrated control panel ● - Amplifier (available in two types: 2 channel with two non-switched differential channels, or a 12 ● channel with 4 non-switched differential and 8 switched referential channels. The number of available channels is controlled by a software license) - Laptop or Desktop computer (Windows OS) with keyboard and mouse ● - Display monitor ● - Summit software The Sierra Summit has the following optional accessories/components: - Remote Head Box (for 3-12 channel amplifier) ● - StimTroller (Hand Held Electrical Stimulator) - Electrical Stimulator Switch Box ● - Footswitch (single) ● - Visual Stimulators (LED Goggles, LCD Checks) - VEP Calibration Sensor - Headphones or other auditory transducers - Reflex Hammer - Temperature Probe ● - Cart - Isolation Transformer or Medical Grade Power Strip - Printer

ViMove is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.

ViMove is comprised of five key components: - 4 Wireless Sensors (2 for movement and 2 for muscle activity) - Disposable Application Pads for holding the wireless sensors. movement (DAP-M) and muscle (DAP-E) sensors - Recording and Feedback Device (RFD) is worn in the patient's pocket or within one meter of the sensors - Recharging Cradle - ViMove software package

Surface Electromyography with range of motion functional capacity assessment grip and pinch strength. The Intended Use Section is identical to the original device PMRU (K022719) To provide non-invasive muscle testing integrating with range of motion, functional capacity of lifting, pulling, pushing, pinching and gripping. To pinpoint muscle activity during movement objectively isolating abnormal movements with abnormal muscle patterns. To establish relative functioning of muscle in any specific anomaly that may occur due to muscle damage, muscle fatigue, hypertonicity or stress. To pinpoint referred pain pattern associated with cervical, thoracic, lumbosacral upper and lower extremities, and refer pain sources. To evaluate a baseline muscle activity for preemployment screening, sport medicine. To look at chronic vs. acute muscle function and range of motion to ascertain good effort with FCE, range of motion, and gripping, and pinch. To ascertain the ischemic activity of muscles. To ascertain chronic damage to muscles. To monitor the frequency range for cardiac muscle.

The Physical Monitoring Registration Unit-S, (PMRU-S) like the legally cleared PMRU combines surface EMG with functional capacity sensors range of motion, grip and pinch strength sensors. This integration allows for a reproducible, objective interpretation of muscle function and effort via the range of motion, fce, pinch and grip. All muscle groups of the body from cervical (to mid back, low back and extremities can be monitored with the device). Bilateral muscle testing is done to compare antagonist muscle groups. The devices monitors bilateral muscle activity with the force produced by the patient while he or she pulls on the strain gauge, with the range of motion. is to provide non-invasive muscle testing integrating with range of motion, functional capacity of lifting, pulling, pushing, pinching and gripping. To measure surface emg along the spine, extremities or cervical region. To measure the EMG with functional tasks, to measure the EMG with range of motion, to measure the EMG with pinch and or grip. This this is identical to the already cleared PMRU.

The PBI MyoVision 3G WireFree™ Systems are indicated to provide the clinician with EMG activity, skin temperature, angles of the patient's motion information during therapies that include muscle relaxation training and re-education.

The MyoVision 3G WireFree™ System consists of handheld scanner devices which receive and transmit signals to a system hub. The data from the devices is displayed on a personal computer. The MyoVision 3G WireFree™ System is designed to measure and visually present physiological signals corresponding to muscle activity (surface EMG), range of motion, and maps of heat generated by the human body. This device is intended to provide the clinician with a patient's EMG activity, skin temperature, and range of motion during therapies that include muscle relaxation training and re-education. The MyoVision 3G WireFree™ System consists of four (4) physiological parameter scanners, a system hub, and proprietary application software. The four scanners are the static surface EMG scanners (ScanVision™), dynamic surface EMG scanner (DynaVision™), range of motion inclinometers (FlexVision™), and thermograph (ThermoVision™). Data collected by the scanners is wirelessly transmitted to a computer via a system hub (either SoloVision™ or PhysioMonitor™) for data processing, data storage, and visual display. The wireless feature provides for data collection efficiency and ease of use. The proprietary application software was developed and validated by Precision Biometrics, Inc. (PBI).

Surface electromyography with video recording, range of motion tracking, isometric functional testing and pinch and grip strength measuring.

The CMAP Pro™ is a stand-alone, battery operated dynamic muscle function monitoring system, with a number of surface electromyography (sEMG) sensors connected to various parts of the subject's body for data collection. The data are then directly fed into a system for conditioning, acquiring, and transmitting sensor data. Analyzed signals include sEMG readings, motion detection, and muscle strength measurements. The system acquires continuous analog signals and then digitizes these signals by sampling at a rate of 2kHz. These data are then transferred wirelessly to an all-in-one PC for processing using software.. The system is capable of monitoring and video recording data from (SEMG) sensors connected to various muscle groups in the human body. During the acquisition of sEMG signals, the system will simultaneously acquire motion tracking of the body, isometric functional testing and pinch and grip strength measuring.

The Focus is intended for use by a healthcare provider to perform nerve conductions and EMG studies as an aid in the evaluation of patients with diseases of muscle and nerves. The machine can also use electrical stimulus or sound stimulus for evoked potentials (EP) studies.

The Focus is a 2-channel neurodiagnostic testing system designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular systems in a clinical environment. The system enables the healthcare provider to perform evoked potentials, nerve conductions and needle EMG studies as an aid in the evaluation of patients with central and peripheral nervous system symptoms. The device provides functionality for the Electromyography (EMG), Nerve Conduction Studies (NCS), and Evoked Potential (EP) testing for a range of clinical applications and has a fast, intuitive and flexible graphical user interface (GUI) that conforms to a Windows philosophy. The Focus EMG Device consists of a handheld electronic unit, a stimulator unit with steel electrodes and felt pads, and a footswitch.

The CERSR® Electromyography System is intended to be used by properly trained technicians and/or physicians in clinical settings. The CERSR® Electromyography System is indicated for use to monitor and display the bioelectric signals produced by muscles to aid in the diagnosis and prognosis of muscular disease or dysfunction.

The CERSR® is an Electromyography System. The CERSR® Electromyography System is specifically designed for a real-time recording of muscle electrophysiology. The CERSR® Electromyography System allows for a real-time recording from multiple locations by applying an array of surface electrodes over the anatomical region of interest. Each electrode is connected to its own channel with a preamplifier, amplifier, buffers and filters. The CERSR® Electromyography System produces a user display of the myoelectric signals. These recordings may be viewed in one of three standard formats, as a typical waveform, RMS display or a frequency spectral analysis plot. The system consists of the following components: 1) a system cart comprised of a CPU: 2) a mouse and keyboard; 3) monitor; 4) printer; 5) two buffer amplifiers; 6) power distribution box. which contains a filter buffer box; 7) isolation transformer; 8) two power supplies; and 9) a static ground system. The CERSR® system contains software and includes a disposable electrode array. Additional accessories provided with the system include a goniometer, a flexible transparent ruler, and two 3-pound weights.