FDA.reportPublic FDA data

IMEDISYNC INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30237071513023707151IMEDISYNC INC.1N2026-01-015th Floor, 520 Teheran-ro Gangnam-gu Seoul KR 06181

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
08800108500363iSyncWave - 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.+8215334080cs@imedisync.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3084101893220722K222838iSyncBrain©-COLU2023-03-16
3084101519479150K220056iSyncWaveGWQ2022-08-10

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OLU12023-03-16
GWQ12022-08-10

PMN#

GUDID#

iSyncWave - 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.

iMediSync, Inc.

2022-08-25