iSyncWave

iSyncWaveTM is a wireless EEG measurement device that applies dry EEG measurement technology to an international 10-20 system compliant size-adjustable headset. iSyncWaveTM measures 19…

Registry build 21.09.26

iSyncWaveTM is a wireless EEG measurement device that applies dry EEG measurement technology to an international 10-20 system compliant size-adjustable headset. iSyncWaveTM measures 19 channel EEG in real time and transfers the data through BLE wireless connection to the iSyncWaveTM App. The data is displayed and recorded via the iSyncWaveTM App. iSyncWaveTM uses dry electrode technology, which doesn’t require a preparation 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 the impedance check screen in the iSyncWaveTM app. An EEG amplifier, analog-to-digital converter and Bluetooth are built in the device. All EEG signal is sampled at 250 Hz and then converted to digital data at 24-bit resolution. This device measures overall EEG data using 19 EEG electrodes, 1 Reference cable and 1 ground electrode. The measured data can be digitally converted to common average, longitudinal and transverse montage. The measured data is automatically uploaded to a secure cloud server via Wi-Fi connection and saved securely. The data saved in the cloud server can be seen on the iSyncWaveTM app. iSyncWaveTM can be only used by professional and/or medical personnel with product training and experience in EEG measurement. The professional and/or medical personnel can check the signal quality in real time and refer to the measured data in clinical practice.

3manufacturers in China registered for this device type
1catalogue number
1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (1), Jiangsu (1), Shaanxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GWQ
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Xian Friendship Medical Electronics Co., Ltd. Xi’An Shaanxi Contract manufacturer 10
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57

Record

Regulatory record for iSyncWave
Listed by Imedisync Inc., South Korea
FDA product code GWQ
Device type Full-Montage Standard Electroencephalograph
Device class Class 2
Regulation 21 CFR 882.1400
Establishment Manufacturer
510(k) K220056
Record published 2022-08-25
Record revised 2022-11-28 (version 2)

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for iSyncWave
Catalogue number Size Status
ISW-MUS101 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Natus Xltek 54
Trackit Lifelines Ltd. 24
Full-Montage Standard Electroencephalograph Nihon Kohden Corp. 20
Enobio Dx Neuroelectrics Barcelona SL 19
Compumedics Neuvo Compumedics Limited 19
Natus Natus Neurology Incorporated 18
X-Series Advanced Brain Monitoring, Inc. 16
Full-Montage Standard Electroencephalograph Nihon Kohden America, Inc. 15
Grass Xltek 13
Seer Home Seer Medical Pty, Ltd. 10
Compumedics SynAmps RT Compumedics Limited 9
Component Neuromonitoring System Moberg Research, Inc. 9

Showing 12 of 131. All products under Full-Montage Standard Electroencephalograph

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K220056 2022-08-10

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer