Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014632167

FEI Number

3014632167

Entity Name

Laizhou Health Ice Pack Co., Ltd.

City/State/Country

Laizhou Shandong, CN

Establishment Address

Xiaoyuan Village,Chenggang Road Street, Laizhou Shandong 261400, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Laizhou Health Ice Pack Co., Ltd. (Owner Number: 10057849)

Owner / Operator Contact Address

Xiaoyuan Village, Chenggang Road Street, Laizhou, CN-SD 261400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Instant Ice Pack & Hot Pack Ice Pack , Hot & Cold Pack , Hand Warmer, Cool Gel Mat Cool Gel Eye Mask , Ice Box , Bottle Cooler , Cool Scarf , Cool Cap , Ice Pillow , Ice Bead Products

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	2018-06-03
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2018-06-03

Official Correspondent

Jing Ma

US Agent Details

FANFEI LIU Email: U.S.agent@frosatechnology.com Phone: (626) 8261385

Related Public Records

Same Entity

Laizhou Health Ice Pack 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 3014632167. Last updated year: 2026. Please use registration number 3014632167 when referencing this establishment in official correspondence.