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The eVox System is intended for the acquisition, display, and storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and event-related potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis.

The eVox System is intended for the acquisition, display, and storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and event-related potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis. The medical system includes the "eVox System" amplifier device, accessories, and a computer (laptop computer or tablet device with internal battery and power cord). The hardware and ancillary components used in conjunction with the eVox System include an EEG cap, the eVox Amplifier, a charging kit (that consists of a USB cable, clip kit, and wall adapter), a Subject Response Device and a Base Station laptop computer. The software on the Base Station laptop computer is intended for device functioning. The eVox System consists of two software components: . Base Station laptop computer software: pre-loaded Evoke software EVO-002-400-BIATS. . Firmware running on the eVox Amplifier PN SW-MSP430. The Base Station laptop is running on a Windows Operating System and is paired with the eVox Amplifier with Bluetooth wireless technology. The Evoke software runs on the Base Station computer and has a graphic user interface that allows the clinician to set up a patient and create a new patient record, conduct a study to collect EEG and ERP data, view live EEG and ERP data on the Base Station monitor, and export recorded data to a file. Firmware for the eVox System resides on the eVox Amplifier. The purpose of the eVox amplifier firmware is to acquire electrophysiology data from the patient and transmit it to the Base Station. The Amplifier operational mode is controlled wirelessly via the Evoke software. In addition to 19 channels of EEG recording the device includes a mode to measure the cap electrode impedances. This is useful for determining if the electrodes are making a good electrical connection with the scalp at each electrode location. The primary software outputs are EEG and ERP data files. These data files are written as floating point numbers in binary format, which represent the electrical potential on each of the 19 EEG channels in microvolts. The eVox System amplifier device does not come in direct contact with patients. Accessories that contact patients, such as the EEG electrode cap, are the same as used with legally marketed devices or are comprised of the same materials as legally marketed accessories. The eVox System is intended for prescription use in any healthcare, medical, or athletic or sports clinics, or outside of medical facilities such as in the sports arena under the supervision of a physician. Also, investigations can be performed outside of healthcare facilities, as long as they are led by qualified medical personnel. The device is not sterile. The device is intended for use by qualified medical personnel only and qualifies for exemption per 21 CFR 801 Subpart D «Prescription devices».