Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016969935

FEI Number

3016969935

Entity Name

SHANGHAI YOUWEN MEDICAL TECHNOLOGY CO.,LTD.

City/State/Country

Shanghai, CN

Establishment Address

Room 202, Building A, No. 689 Qinwan Road, Jinshan District, Shanghai 201515, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shanghai Youwen Medical Technology Co.,Ltd. (Owner Number: 10083175)

Owner / Operator Contact Address

Room 202, Building A, No. 689 Qinwan Road, Jinshan District, Shanghai, CN-NOTA 201515, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hot&Cold / Therapy Pad; Hot&Cold / Water Therapy Wrap; Cold therapy machine; Cold therapy unit; Cold therapy system Disposable Hot&Cold / Therapy Pad; Disposable Hot&Cold / Water Therapy Wrap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2021-10-31

Official Correspondent

Honggang Chen

US Agent Details

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

Related Public Records

Same Entity

Shanghai Youwen Medical Technology Co.,Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016969935. Last updated year: 2026. Please use registration number 3016969935 when referencing this establishment in official correspondence.