Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023707151

FEI Number

3023707151

Entity Name

IMEDISYNC INC.

City/State/Country

Gangnam-gu Seoul, KR

Establishment Address

5th Floor, 520 Teheran-ro, Gangnam-gu Seoul 06181, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

iMediSync Inc. (Owner Number: 10085850)

Owner / Operator Contact Address

15th Floor, 411 Teheran-ro, Gangnam-gu, KR-11 06160, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220056

PMA Number

N/A

All Registered Proprietary Names

iSyncBrain-C iSyncWave

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLU	Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2023-03-28
OLX	Source Localization Software For Electroencephalograph Or Magnetoencephalograph	Neurology	Class 2	882.1400	2023-03-28
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2022-08-22
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2022-08-22

Official Correspondent

No official correspondent registered.

US Agent Details

Newman William Kody Business: Kody Email: kody@imedisync.com Phone: (480) 2290054

Related Public Records

Same Entity

iMediSync Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.

Similar Registrations

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3008008477	G.TEC MEDICAL ENGINEERING GMBH	Graz Steiermark, AT
3005713796	G.TEC MEDICAL ENGINEERING GMBH	SCHIEDLBERG Oberosterreich, AT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023707151. Last updated year: 2026. Please use registration number 3023707151 when referencing this establishment in official correspondence.