Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010580813

FEI Number

3010580813

Entity Name

WOOSHIN LABOTTACH CO., LTD.

City/State/Country

Incheon Gyeonggi, KR

Establishment Address

30 Songdomirae-ro, Yeonsu-gu,, Songdo BRC SMART Valley B 109, 914, 915, 1013, 1014, 1015, 1018, 1019., Incheon Gyeonggi 21990, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Wooshin Labottach Co., Ltd. (Owner Number: 10049099)

Owner / Operator Contact Address

1907,DAERUNG POST TOWER I, 288, Guro-Dong, Guro-Gu, Seoul, KR-11 152-050, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Body Warmer Patch Icy Menthol Pain Relief Patch Friopad Patch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2015-04-14

Official Correspondent

Tack Soo Nam

US Agent Details

Leonard Krause Business: FDA Connect, inc. Email: lkrause@fda-connect.com Phone: (541) 2323030

Related Public Records

Same Entity

Wooshin Labottach 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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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3003255790	WITKO INCORPORATED	Wolcott, IN, US
3008742818	PT. Hisamitsu Pharma Indonesia	Sidoarjo Jawa Timur, ID

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010580813. Last updated year: 2026. Please use registration number 3010580813 when referencing this establishment in official correspondence.