Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014542717

FEI Number

3014542717

Entity Name

HUAIAN YOUWEN MEDICAL TECHNOLOGY CO.,LTD

City/State/Country

HUAIAN Jiangsu, CN

Establishment Address

MINBING ROAD, EAST SHUANGGOU TOWN, HONGZE DISTRICT, HUAIAN Jiangsu 223121, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HUAIAN YOUWEN MEDICAL TECHNOLOGY CO.,LTD (Owner Number: 10058861)

Owner / Operator Contact Address

MINBING ROAD, EAST SHUANGGOU TOWN, HONGZE DISTRICT, HUAIAN, CN-JS 223121, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sleeve, Limb, Compressible Garment Ice Bucket; Cold Therapy System Hot&Cold/Therapy Pad, Hot&Cold/Water Therapy Wrap Hot&Cold / Therapy Pad , Hot&Cold / Water Therapy Wrap, Cold Therapy System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2018-11-04
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2018-11-04
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2018-11-04
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2020-02-23

Official Correspondent

Jun Meng

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

HUAIAN YOUWEN MEDICAL 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
K242140	Jiale Health Technology Shenzhen Co., Ltd.	Air Compression Leg Massager (K-705)	2025-03-17
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04
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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3016472144	MEDELLA HEALTH LTD	Tauranga Bay of Plenty, NZ
3014834638	ZENITH TECHNICAL INNOVATIONS, LLC	Gurnee, IL, US
3002849858	CERAGEM CO., LTD.	Cheonan-si, Seobuk-gu Chungnam, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014542717. Last updated year: 2026. Please use registration number 3014542717 when referencing this establishment in official correspondence.