iSyncWave

GUDID 08800108500363

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.

iMediSync, Inc.

Electroencephalograph

• Primary Device ID: 08800108500363
• NIH Device Record Key: 33573c67-46a4-4d90-a0bb-8f63e417f3ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iSyncWave
• Version Model Number: ISW-MUS101
• Company DUNS: 694063068
• Company Name: iMediSync, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com
• Phone: +8215334080
• Email: cs@imedisync.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800108500363 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220056

FDA Product Code

• GWQ: Full-Montage Standard Electroencephalograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-02
• Device Publish Date: 2022-08-25