Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029915537

FEI Number

3029915537

Entity Name

WELLYSIS CORP.

City/State/Country

Gangnam-gu, Seoul, KR

Establishment Address

8F, 425 Teheran-ro,, Gangnam-gu, Seoul 06159, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Wellysis Corp. (Owner Number: 10088983)

Owner / Operator Contact Address

8F, 425 Teheran-ro,, Gangnam-gu,, KR-11 06159, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231289

PMA Number

N/A

All Registered Proprietary Names

S-Patch ExL S-Patch Ex

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2024-02-20
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2023-10-26

Official Correspondent

Young Juhn

US Agent Details

Dennis Ahn Business: Wellysis USA Inc. Email: dennis.ahn@wellysis.com Phone: (217) 2986850

Related Public Records

Same Entity

Wellysis Corp.

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 3029915537. Last updated year: 2026. Please use registration number 3029915537 when referencing this establishment in official correspondence.