Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015525234

FEI Number

3015525234

Entity Name

JIANGSU YOUXIN ICE PACK CO., LTD

City/State/Country

Huaian Jiangsu, CN

Establishment Address

South of Yingbin Street, Maba Economic Development Zone, Xuyi County, Huaian Jiangsu 211751, CN

Establishment Type(s)

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

Owner / Operator

Jiangsu Youxin Ice Pack Co., Ltd (Owner Number: 10060644)

Owner / Operator Contact Address

South of Yingbin Street, Maba Economic Development Zone, Xuyi County, Huaian, CN-JS 211751, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BOCO18F-WH-08-HOT (Sport+Back) Hand Warmer SOMA19F-WH-08-HOT (Sport+Back) SOMA19F-WH-10-HOT Nek/Shoulder BOCO18F-WH-10-HOT N&S Hand Warmer SOMA19F-WH-08-HOT (Sport+Back) SOMA19F-WH-10-HOT Nek/Shoulder BOCO18F-WH-08-HOT (Sport+Back) BOCO18F-WH-10-HOT N&S Revanesse Gel Pack CF Hip Wrap

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	2019-06-05
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2019-06-05

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Jiangsu Youxin 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

Similar Registrations

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3031595576	SUZHOU SMH CO., LTD.	Suzhou Jiangsu, CN
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 3015525234. Last updated year: 2026. Please use registration number 3015525234 when referencing this establishment in official correspondence.