Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013924508

FEI Number

3013924508

Entity Name

GCS CO.,LTD

City/State/Country

Seongnam-si Gyeonggi, KR

Establishment Address

#301~327, 33, Sagimakgol-ro 62beon-gil, Jungwon-gu, Seongnam-si Gyeonggi 13211, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GCS Co.,LTD (Owner Number: 10057779)

Owner / Operator Contact Address

#301~327, 33, Sagimakgol-ro 62beon-gil, Jungwon-gu, Seongnam-si, KR-41 13211, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LEAF SYNAPLUS SYNA+ Plasmatique SYNAPLUS PRO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2018-05-24

Official Correspondent

No official correspondent registered.

US Agent Details

Cynthia Ipach Business: Compliance Insight, Inc. Email: Cipach@Compliance-Insight.com Phone: (513) 8603512

Related Public Records

Same Entity

GCS Co.,LTD

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013924508. Last updated year: 2026. Please use registration number 3013924508 when referencing this establishment in official correspondence.