Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009538555

FEI Number

3009538555

Entity Name

KOOLCARE TECHNOLOGY CO., LTD

City/State/Country

Xuzhou Jiangsu, CN

Establishment Address

Wenlv Healthcare Park, No.18, Zhenbei Road, Xinyi, Xuzhou Jiangsu 221400, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Koolcare Technology Co., Ltd (Owner Number: 10039736)

Owner / Operator Contact Address

Wenlv Healthcare Park, No.18, Zhenbei Road, Xinyi, Xuzhou, CN-JS 221400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hot or cold pack disposable Hot pack disposable Pain relief ginger patch Migraine hydrogel patch Ultra strength pain relieving patch Equate WMTICE-100J Cold&hot medicated patch Pain relief gel-roll on Pain relief gel patch Pain relief menthol patch Elastic relief strip Fever cooling patch (cooling gel patch) Pain relief gel-tube Capsicum patch Adhesive backed thermal skin patches Lidocaine patch Joint, Knee External Brace Koolcare Hot and cold pack reusable Ice gel pack, multiple

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	2012-02-06
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2015-09-24
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2015-09-24
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2012-02-06

Official Correspondent

Fanny Zhao

US Agent Details

Fanny Zhao Business: J & F Technology Service Email: info@jf-yiliao.com Phone: (909) 5100201

Related Public Records

Same Entity

Koolcare Technology 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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3017103360	RAIN EYE DROPS LLC	Wilmington, DE, US
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 3009538555. Last updated year: 2026. Please use registration number 3009538555 when referencing this establishment in official correspondence.