Duns Number:694063068
Device Description: iSyncWaveTM is a wireless EEG measurement device that applies dry EEG measurementtechnolog 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.
Catalog Number
-
Brand Name
iSyncWave
Version/Model Number
ISW-MUS101
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K220056
Product Code
GWQ
Product Code Name
Full-Montage Standard Electroencephalograph
Public Device Record Key
33573c67-46a4-4d90-a0bb-8f63e417f3ee
Public Version Date
September 02, 2022
Public Version Number
1
DI Record Publish Date
August 25, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |