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The Flexset system is intended for prescription use in a healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The Flexset system acquires, transmits, displays and stores electroencephalogram (EEG), and optionally electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), orientation sensor data, photic sensor data, external trigger signals and video.

The Flexset System is intended to acquire, transmit, display and store primarily EEG and optionally auxiliary signals. Specific transport environments in the Indications for Use include ambulances, cars, buses, trains, boats and via air, per stipulation in the user manual of the device. The Flexset headset is designed to record a full montage EEG, with optional external references and additionally up to 8 auxiliary channels using lead wires for EEG, EOG, ECG or EMG. The device consists of the following components: - Flexset (Headset) . - Electrodes - Charger with cable ● - Display Unit ● - Extension Unit ● - Lead wires ● - Software ● - Display Unit firmware o - Data center application (same as K172735) O - O Client application (same as K172735)

The WR19 System is intended for prescription use in a health care facility or clinical research environment to acquire, transmit, display and store primarily EEG and optional auxiliary signals for adults and children, not including newborns. The WR19 System requires operation by a healthcare professional familiar with EEG. The WR19 System acquires, transmits, displays and stores electroencephalogram (EEG), and optionally electrocardiogram (ECG), accelerometer, photic sensor, external trigger signals and video.

The WR19 System is primarily intended to acquire, transmit, display and store EEG and optionally do so for auxiliary signals. WR19 headset is designed to perform Routine or Outpatient EEG using 19 dry signal electrodes and 1 dedicated dry ground/driven-right-leg (DRL) electrode, adjusted and placed to comply with the 10-20 EEG system. The device consists of the following components: - . Headset - Electrodes (affixed to the underside of the headset) ● - Charger - Charging cable . - Software ● - Headset firmware - - Client application - - Data center application