iMediSync, Inc.

Address:3th Floor, 175 Yeoksam-ro,Gangnam-gu Seoul,KR

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Device Description : iSyncWaveTM is a wireless EEG measurement device that applies dry EEG measuremen iSyncWaveTM is a wireless EEG measurement device that applies dry EEG measurementtechnology to an international 10-20 system compliant size-adjustable headset.iSyncWaveTM measures 19 channel EEG in real time and transfers the data through BLEwireless connection to the iSyncWaveTM App. The data is displayed and recorded via theiSyncWaveTM App. iSyncWaveTM uses dry electrode technology, which doesn’t require apreparation process(e.g., applying conductive gel), to obtain high quality EEG signals.Before measuring the EEG, you can check the impedance of each electrode under theimpedance check screen in the iSyncWaveTM app. An EEG amplifier, analog-to-digitalconverter and Bluetooth are built in the device. All EEG signal is sampled at 250 Hz andthen converted to digital data at 24-bit resolution.This device measures overall EEG data using 19 EEG electrodes, 1 Reference cable and1 ground electrode. The measured data can be digitally converted to common average,longitudinal and transverse montage. The measured data is automatically uploaded toa secure cloud server via Wi-Fi connection and saved securely. The data saved in thecloud server can be seen on the iSyncWaveTM app.iSyncWaveTM can be only used by professional and/or medical personnel with producttraining and experience in EEG measurement. The professional and/or medicalpersonnel can check the signal quality in real time and refer to the measured data inclinical practice.

Device Class : 2

Duns Number: 694063068

Premarket Exempt : No

Product Code : GWQ, GXY

Prescription Use : Yes

Device Count : 1