DEVICE: iSyncWave (08800108500363)
Device Identifier (DI) Information
iSyncWave
ISW-MUS101
In Commercial Distribution
iMediSync, Inc.
ISW-MUS101
In Commercial Distribution
iMediSync, Inc.
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.
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
11467 | Electroencephalograph |
An electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GWQ | Full-Montage Standard Electroencephalograph |
GXY | Electrode, Cutaneous |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K220056 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
33573c67-46a4-4d90-a0bb-8f63e417f3ee
November 28, 2022
2
August 25, 2022
November 28, 2022
2
August 25, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+8215334080
cs@imedisync.com
cs@imedisync.com