ISyncWave
Full-montage Standard Electroencephalograph
IMediSync Inc.
The following data is part of a premarket notification filed by Imedisync Inc. with the FDA for Isyncwave.
Pre-market Notification Details
| Device ID | K220056 |
| 510k Number | K220056 |
| Device Name: | ISyncWave |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | iMediSync Inc. 3rd FL. 175 Yeoksam-ro, Gangnam-gu Seoul, KR 06247 |
| Contact | Seung Wan Kang |
| Correspondent | Young-Geun Kim iMediSync Inc. 3rd FL. 175 Yeoksam-ro, Gangnam-gu Seoul, KR 06247 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-06 |
| Decision Date | 2022-08-10 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800108500363 | K220056 | 000 |
Trademark Results [ISyncWave]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ISYNCWAVE 79303256 not registered Live/Pending |
iMediSync, Inc. 2020-12-18 |
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