Data / Medical devices / South Korea / Imedisync Inc.

Imedisync Inc.: FDA-registered device maker in Gangnam-gu Seoul, South Korea, 2 510(k) clearances

Name: Imedisync Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Imedisync Inc. is registered with the FDA (registration 3023707151) in Gangnam-gu Seoul, South Korea. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 16, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3023707151
Address: 5th Floor, 520 Teheran-ro, Gangnam-gu Seoul, South Korea, 06181
Owner or operator: iMediSync Inc. (10085850)
Roles: Manufacturer
First device listed: August 22, 2022
Registered through: 2026
Brand names listed: iSyncBrain-C, iSyncWave

Devices it lists

Device	Product code	Class	Role	Source
Electrode, Cutaneous	GXY	2	Manufacturer	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Manufacturer	accessdata.fda.gov
Normalizing Quantitative Electroencephalograph Software	OLU	2	Manufacturer	accessdata.fda.gov
Source Localization Software For Electroencephalograph Or Magnetoencephalograph	OLX	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 16, 2023	K222838	iSyncBrain©-C	OLU	Substantially Equivalent	iMediSync, Inc.	accessdata.fda.gov
August 10, 2022	K220056	iSyncWave	GWQ	Substantially Equivalent	iMediSync, Inc.	accessdata.fda.gov

Compare with other makers

Updated March 16, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.