Search Results

The REMI Remote EEG Monitoring System is indicated for use in healthcare settings where near real-time and/or remote EEG is warranted and in ambulatory settings where remote EEG is warranted. REMI System uses single patient, disposable, wearable sensors intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for a duration up to 30 days. REMI System uses the REMI Mobile software application that runs on qualified commercial off-the-shelf mobile computing platforms. REMI Mobile displays user setup information to trained medical professionals and provides notifications to medical professionals and ambulatory users. REMI Mobile receives and transmits data from connected REMI Sensors to the secure REMI Cloud where it is stored and prepared for review on qualified EEG viewing software. REMI System does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor. REMI System is indicated for use with adult and pediatric patients (1+ years).

The REMI System has three major components: - 1. REMI Sensor A disposable EEG sensor which is placed on the patient's scalp using a conductive REMI Sticker - 2. REMI Mobile A mobile medical application that is designed to run on a qualified commercial-off-the-shelf mobile computing platform (an Android tablet for use in healthcare settings, and a portable/wearable Android device (phone or smartwatch) for use in ambulatory settings), acquire EEG data transmitted from REMI Sensors and then transmit the EEG data and associated patient information via wireless encrypted transmission to. - 3. REMI Cloud A HIPAA-compliant secure cloud storage and data processing platform where data is processed into a qualified EEG reviewing software format for neurological review.

The Natus BrainWatch System including the Natus BrainWatch Headband, is intended to record and store EEG signals and present these signals visually to assist trained medical staff in making neurological diagnoses in patients aged 2 years and older. The device does not provide any diagnostic conclusions about the subject's condition and does not provide any automated alerts of an adverse clinical event. The Natus BrainWatch System is intended for use within a professional healthcare facility or clinical research environment. The Natus BrainWatch Headband is intended for single-patient use.

The Natus BrainWatch system is a reliable, mobile, and easy-to-use EEG device intended to record, store, and visually present EEG signals to assist trained medical staff in making neurological diagnoses in patients. The system includes a touchscreen tablet as its primary interface. The Natus BrainWatch Headband is a single-use disposable headpiece with an integrated array of 10 passive electrodes that are applied to the patient's head to record EEG signals when connected to an amplifier. The Natus BrainWatch System consists of the following components: Tablet, IV Pole Handle, Amplifier, Headband(s), Gel Pods and a Mobile Application: - Touchscreen Tablet with charger - Single-Use disposable elastic fabric headband with 10 electrodes (available in sizes Small, Medium, and Large) containing: - Hydroflex patch with 2 built-in electrodes - 8 electrodes attached to gel pods used to improve impedance levels labeled L1-L4, R1-R4 - Wireless amplifier that attaches to the headband and connects to the tablet via Bluetooth - IV pole handle that holds the tablet for a hands-free experience - Gels pods attach to the electrodes to improve impedance levels The Natus BrainWatch System is a portable 10-channel EEG monitoring system. 10 patient electrodes are used to record the 10 channels. Channels 1-5 should be used for the patient's left hemisphere, with channel 1 at the front of the patient's head and channel 5 at the back. Channels 6-10 should be used for the patient's right hemisphere, with channel 6 at the front of the patient's head and channel 10 at the back. EEG recording files are transferred wirelessly to a computer from the Natus BrainWatch Tablet using a Wi-Fi connection. The EEG sessions from Natus BrainWatch are stored using a cloudbased solution which allows the end user to view studies at a later date. Recorded sessions can be reviewed remotely on a computer using the Neuroworks EEG software. The device is a portable, 10-channel EEG monitoring system. The device connects to a headband consisting of 10 patient electrodes which are used to form the 10 channels and may be used with any scalp EEG electrodes. The system acquires the EEG signals of a patient and presents the EEG signals in visual formats in real time. The EEG recordings are displayed on a computer or tablet using an EEG viewer software. The visual signals assist trained medical staff to make neurological diagnoses. It does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. Micro-USB cable is used to connect the Natus BrainWatch System to power adapter for charging. Bluetooth is used to connect amplifier with tablet to transfer EEG recording files. When the Natus BrainWatch System is connected to a power adapter of a computer, all EEG acquisition functions are automatically disabled.

The QUEX ED and QUEX S device is indicated for use as an Electrophysiological System. The Electrophysiological System is made up of the following Items which are functions of the QUEX ED and S device: 1. Two channel EEG: The QUEX ED and S Device is intended to record and store EEG signals, and to present the EEG signals in visual formats in real time. The visual signals assist trained medical staff to make neurological diagnoses. The EEG device does not provide any diagnoses conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The QUEX ED AND S Device is intended to be used in a professional healthcare facility environment. 2. GSR [galvanic skin response measuring] The QUEX ED and S device is intended for use by trained healthcare professionals, to detect and monitor electrical signals produced by the body skin conductance by using electrodes placed on the skin.

QUEX ED or QUEX S devices are contains the following components: - QUEX ED or QUEX S hardware. - I QUEX Monitor software - . USB - USB cable for data communication and power supply. - EEG electrodes (head electrodes) - Electrodes for GSR measurements (limbs) - I Cable harnesses for head and limbs. The QUEX Monitor software is exclusively used for QUEX ED or QUEX S as part of the system. The EEG electrodes and the electrodes used for GSR measurements are connected to the QUEX ED or S devices. The device makes the necessary gain on the analog signals and digitalize the signals. The digitalized information is acquired and displayed by the QUEX Monitor software. The QUEX monitor software can run on PCs, notebooks with Windows OS. Electroencephalography (EEG), measures brain wave activity. The system uses the head harness and electrodes to acquire the signals. The QUEX Devices are measures brain activity on two channels. The EEG wave recording electrodes are connected to the forehead with dry electrodes. The galvanic skin response (GSR, which falls under the umbrella term of electrodermal activity, or EDA) refers to changes in sweat gland activity. The GSR recording is done via limb electrodes attached to the wrists and ankles.

The SignalNED Device is intended to record and display Quantitative EEG (qEEG) (relative band power, e.g., alpha, beta, delta, theta), which is intended to help the user analyze the EEG. The SignalNED does not provide any diagnostic conclusion about the patient's condition. The device is intended to be used on adults by qualified medical and clinical professionals. The SignalNED is intended to be used in a professional healthcare environment.

The SignalNED Model RE machine uses 10 patient electrodes (4 left, 4 right, 2 midh are used to form the 8 channels. The SignalNED machine requires the use of the SignalNED Sensor Cap, and the system includes the following components: - Portable EEG machine (Device) - I Battery & External Battery Charger - I SignalNED Sensor Cap - I SignalNED Sensor Cap Cable The primary function of the SignalNED Model RE is to rapidly record EEG and derive the Quantitative EEG (qEEG) measurement of Relative Band Power for multiple bands (e.g., alpha, beta, theta) at each electrode. These measurements are intended to help the user analyze the underlying EEG. The SignalNED Model RE (client) achieves its intended without relying on wireless comectivity. The SignalNED RE does not provide any diagnostic conclusion about the patient's condition.

The REMI Remote EEG Monitoring System is indicated for use in healthcare settings where near real-time and/or remote EEG is warranted and in ambulatory settings where remote EEG is warranted. REMI uses single patient, disposable, wearable sensors intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for a duration up to 30 days. The REMI System uses the REMI-Mobile software application that runs on qualified portable general purpose computing platforms. REMI-Mobile displays user setup information to trained medical professionals and provides notifications to medical professionals and ambulatory users. REMI-Mobile receives and transmits data from connected REMI Sensors to the secure REMI-Cloud where it is stored and prepared for review on qualified EEG viewing software. REMI does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor. The REMI System is indicated for use with adult and pediatric patients (6+ years).

The REMI System has three major components: 1) REMI Sensor A disposable EEG sensor which is placed on the patient's scalp using a conductive REMI Sticker 2) REMI Mobile A mobile medical application that is designed to run on a qualified commercial-off-the-shelf mobile computing platform (an Android tablet for use in healthcare settings, and a portable/wearable Android smartwatch for use in ambulatory settings), acquire EEG data transmitted from REMI Sensors and then transmit the EEG data and associated patient information via wireless encrypted transmission to, 3) REMI Cloud A HIPAA-compliant secure cloud storage and data processing platform where data is processed into a qualified EEG reviewing software format for neurological review. This 510(k) submission includes the addition of the Android smartwatch for ambulatory use and increases the duration of monitoring to up to 30 days.

The NEBA® Compact EEG 2R Mobile Headset) is intended to capture, amplify, and wirelessly transmit electrical brain activity for review by a trained medical professional using the CEEG2R recording software. The NEBA Headset comprises an electrode positioning system for placing single-use disposable electrodes on the head (Vermed® A10005, ANSI/AAMI EC12 compliant silver/silver-chloride (Ag/AgCl) electrodes). Contained within the headset is a wireless EEG amplifier module. The NEBA Headset and its associated software do not provide any diagnostic conclusion or automated alerts of any clinical event about a patient's condition. The NEBA Headset transmits electrophysiological signals from the electrodes to a CEEG 2R IEC/UL 60950-1 safety compliant computer running the NEBA CEEG 2R recording software. The system supports six electrode locations (CZ, left ocular, right ocular, left ear, right ear, and ground) on four flat flexible leads and one plastic tab (the latter to support the CZ electrode). The CEEG2 Headset is intended for use in clinical settings in individuals six years of age and older. (Rx only).

The NEBA® Compact EEG2R Mobile Headset is a battery powered (3.7v Lithium-lon battery wirelessly charged using a Qi-compliant receiver) wireless (Bluetooth LE) EEG headset which facilitates the placement of EEG electrodes. The NEBA® Compact EEG2R Mobile Headset (CEG2R) has both hardware and software components. Hardware comprises an EEG electrode system that serves to conduct EEG potentials from the human scalp for transfer to a built-in wireless EEG amplifier. The software provides EEG amplifier hardware control, recording, storage, and user interfaces for waveform monitoring, patient information entry and storage, and accessing stored EEG data. The CEEG2R Headset has two primary purposes: To aid in EEG electrode positioning on the head such that electrodes are positioned in intended locations accurately and reliably per the standard 10-20 International Electrode Placement System. The default leads configuration includes CZ, left ocular (OC-L), right ocular (OC-R), left ear (E-L), right ear (E-R), and Ground (GND) positions; To transmit electrophysiological signals from positioned electrodes to an EEG recording and monitoring device via an internal EEG amplifier with wireless transfer communication. The CEEG2R Headset is constructed using biocompatible patient contact surfaces, the major components formed of polyurethane and polyester. The headset is held in place using a flexible platform at the top of the head and adjustable arms that terminate at lateral supports at the sides of the head. The headset is designed for use with accessory disposable silver/silver-chloride (Ag/AgCl) electrodes (K781430). An integral, counter posing pressure tab accepts a disposable electrode for placement at the top medial portion of the head (at location CZ of the 10-20 International Electrode Placement System). Connection components facilitate the quick insertion and removal of the electrodes and flexible leads. Electrodes for use on the scalp and hair bearing scalp region use a low-viscosity integrated wet-gel conductive medium embedded in the electrodes along with integrated low-tack adhesive optimized for hair compatibility and system stability. The system is stabilized on the head through use of low tack adhesive-lined electrodes, conformable lateral support linings, spring hinges, and a flexible headband platform. The system interfaces with the CEG2R recording and monitoring software for signal acquisition, signal measurement, and electrode impedance measurement by way of a built-in wireless amplifier. The battery, wireless battery charger, wireless communication transmitter and amplifier printed circuit board (PCB) are located atop a midline-located headband platform of the headset.

The Neurosteer EEG Recorder is intended to record and store EEG signals, and to present the EEG signals in visual formats in real time. The visuals assist trained medical staff to make neurological diagnoses. The EEG Recorder does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The EEG Recorder is intended to be used in a professional healthcare facility environment.

The Neurosteer brain monitoring platform is a portable single-channel EEG that measures and records electrical activity of the brain. An adhesive electrode strip is affixed to the subject's forehead to capture the brain activity signal. The strip is attached to a sensing device that transmits the signal via low-energy Bluetooth (BLE) to a local brain activity monitor. The brain activity monitor provides technical status indicators about the recording (such as battery level, connection status, and electrode disconnection alert). It can also be used to provide auditory prompt sequences (using an external speaker) during monitoring. The signal is sent via a secure Internet connection to the cloud (either wireless Wi-Fi or physical Ethernet) where the data is stored according to HIPAA quidelines. Data processing performed in the cloud transforms the raw electrical brain activity signal into a display representation of the signal. When the Internet connection is available, both the raw and processed data can be viewed in real-time on the brain activity monitor and through the web portal. When the connection is not available, only the raw data can be viewed in real-time on the brain activity monitor.

The REMI Platform is intended to be used in healthcare settings where near real-time and/or remote EEG is warranted. REMI consists of Epilog disposable Sensors - a single patient, disposable, wearable sensor intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for up to 48 hours. The REM-Mobile software and REMI-Tablet are intended to receive and transmit data from four Epilog Sensors to secure cloud storage for subsequent viewing and reviewing of EEG on third-party software. REMI does not make any diagnosis or recommendations and is intended only as a physiological signal monitor. Epilog Sensors are intended for use by trained medical professional healthcare facility environment. Epilog Sensors are intended for use with adult and pediatric patients (6+). (Rx only).

REMI amplifies the electroencephalogram (EEG) from a patient's scalp. After amplification, the EEG are sent to the REMI-Tablet running the REMI-Mobile Application. REMI-Mobile combines the EEG from four Epilog Sensors and patient information and relays the data to a cloud server running Persyst software. The EEG data is accessible through the Persyst Mobile interface. REMI is designed for use with adult and pediatric patients (6+). The user interface for the REMI-Tablet is an 10" LCD touchscreen display. The user interface for Epilog Sensors is a single button kevpad overmolded in each Sensor, REMI-Tablet power is through A/C adapter as well as limited onboard rechargeable battery. Epilog Sensor power is through a single-use primary coin cell. Using its wireless link, the Epilog Sensors can exchange EEG data and commands with the REMI-Mobile application running on the REMI-Tablet. REMI has three major components: 1) Epilog-D disposable EEG sensors, 2) REMI-Mobile - mobile OS application designed to run on a medical-grade tablet, acquire EEG data transmitted from Epilog devices along with user-entered patient and device information, and then transmit the EEG data and patient/device information via wireless encrypted WiFi to. 3) REMI-Cloud – A HIPAA-compliant cloud storage and data processing platform where data is processed into a format that a FDA-cleared (K171184) EEG reviewing software called Persyst can use, which will allow remote neurological review.

The Byteflies Kit is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, and transmit electrical activity of the brain by placing non-invasive electrodes on the head of patients. It acquires, records and transmits two channels of electroencephalogram (EEG) data. The medical use of data acquired by the Byteflies Kit is to be performed under the direction of a licensed medical professional. The Bytellies Kit does not provide any diagnostic conclusions about the patient's condition.

The Byteflies Kit is a wearable medical device for continuous recording of non-invasive physiological signals in healthcare and home settings. The Byteflies Kit is intended to be configured by a trained healthcare professional and consists of 3 main components: 1. Sensor Dot: a biopotential wearable sensor that measures up to 2 bipolar channels of electroencephalography (EEG). It is powered by a rechargeable battery, can record data for up to 24 hours on a single charge, and has an LED indicator to report the operating status to the user. The sample-level EEG data is continuously stored on the Sensor Dot for later retrieval. 2. Sensor Patch: the interface between a Sensor Dot and non-invasive biopotential electrodes (not provided). It attaches magnetically to the Sensor Dot and has four DIN 42802 connectors. Two commercial disposable EEG electrodes per Sensor Patch channel are connected to the head of the subject in a reduced EEG montage. The Sensor Dot attached to the Sensor Patch is carried by the patient to continuously measure electrical brain activity. 3. Docking Station: up to 5 Sensor Dots can connect magnetically to the Docking Station and transfer recorded data to the Docking Station, while charging their batteries. The recorded sample-level EEG signals can then be downloaded from the Docking Station's Management Interface to a computer via a local WiFi network for long-term storage and further review by a healthcare professional. An AC/DC adapter with micro-USB cable supplies power to the Docking Station.

The AE-120A EEG Head Set is intended to amplify, capture, and wirelessly transmit electrical activity of the brain for review by a trained medical professional using the previously cleared and validated Nihon Kohden electroencephalograph systems (EEG-1200A series and EEG-9100) to assist in the diagnosis of neurological disorders. The AE-120A EEG Head Set and its associated EEG Software do not provide any diagnostic conclusion or automated alerts of an adverse clinical event about a patient's condition. The device is intended for use by trained medical professionals in a medical facility such as a physician's office, laboratory, or clinic. The device is intended for use on adults (ages 18 and above). (Rx Only)

The Nihon Kohden AE-120A EEG Head Set is a battery powered (2 AA, LR6 alkaline disposable) wireless EEG head set which facilitates the placement of disposable EEG electrodes on the patient's scalp. The AE-120A EEG Head Set with the electrodes is then attached to the patient's head using the head set's chin, top, and rear straps. With the head set turned on and secured in place, the head set acquires and amplifies electrical activity via EEG electrodes placed in contact with the patient's scalp. The captured waveforms from these signals are transmitted wirelessly via Bluetooth to a Nihon Kohden specified electroencephalograph through the AE-120A EEG Head Set and receiver. The head set outputs the collected brain electrical activity to the computer component of the electroencephalograph system where a medical professional can review and interpret the information. The AE-120A EEG Head Set has 8 channels for measurement along with one reference and one Z electrode. The electrodes are fixed into position with the head set to approximate the 10-20 electrode positions. The AE-120A EEG Head Set is designed to work with the Nihon Kohden EEG-1200A series and EEG-9100, cleared in K080546 and K011204, respectively. The associated system software is used to facilitate the communication and display of the information from the head set.