Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018448099

FEI Number

3018448099

Entity Name

HANIL MEDICAL CO., LTD.

City/State/Country

Gwangju-si, KR

Establishment Address

147-58, Baekgogae-gil, Gonjiam-eup, Gwangju-si 12806, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HANIL MEDICAL CO., LTD. (Owner Number: 10081266)

Owner / Operator Contact Address

147-58, Baekgogae-gil, Gonjiam-eup, Gwangju-si, KR-NOTA 12806, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Home Use Dry Sauna HEALAX i Shoulder Ceramix mat S1 Ceramix mat M1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRQ	Unit, Heating, Powered	Physical Medicine	Class 1	890.5950	2022-12-27
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2021-03-30
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2021-03-30

Official Correspondent

Tae-yun Chung

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 9225276

Related Public Records

Same Entity

HANIL MEDICAL CO., LTD.

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
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

Similar Registrations

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3010227982	Tianjin Zhengtian Medical Instrument Co., Ltd.	Tianjin, CN
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9610612	AESCULAP AG	TUTTLINGEN, DONAU Baden-Wurttemberg, DE
3017265430	SHENZHEN YOUMAY ELECTRONICS CO., LTD	Shenzhen Guangdong, CN
3011066654	SHENZHEN JOOSE BEAUTY ELECTRONIC CO.,LTD	Shen Zhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018448099. Last updated year: 2026. Please use registration number 3018448099 when referencing this establishment in official correspondence.