Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014675426

FEI Number

3014675426

Entity Name

CHANGZHOU WENYU MEDICAL INSTRUMENTS CO., LTD.

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

No. 49, Tangkou, Niutang, Wujin District, Changzhou Jiangsu 213163, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

CHANGZHOU WENYU MEDICAL INSTRUMENTS CO., LTD. (Owner Number: 10092989)

Owner / Operator Contact Address

No. 49, Tangkou, Niutang, Wujin District, Changzhou, CN-JS 213163, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hot/cold compression, Shoulder brace, neck brace, knee brace, wrist brace, back brace, elbow brace Heat pack, hot bag, Instant cold pack, microwave heating pack bandage ankle support, bandage back support, bandage palm support, elbow support, bandage wrist support, bandage knee support

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2025-03-13
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2025-03-13
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-03-13

Official Correspondent

Duyang Luo

US Agent Details

James St. Wu Business: Humiss Inc. Email: fda-reg@humiss.com Phone: (720) 7595888

Related Public Records

Same Entity

CHANGZHOU WENYU MEDICAL INSTRUMENTS 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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Similar Registrations

Registration Number	Establishment Name	Location
1022826	FILLAUER, LLC	CHATTANOOGA, TN, US
3007942528	WELLPOWER SPORTING GOODS CO., LTD.	Dong Guan Guangdong, CN
2183520	Tenacious Holdings Inc	Saint Paul, MN, US
3010239526	Simple Manufacturing DG Ltd	Dongguan City Guangdong, CN
3030683078	HUILING (XIAMEN) MEDICAL TECHNOLOGY CO., LTD.	Xiamen Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014675426. Last updated year: 2026. Please use registration number 3014675426 when referencing this establishment in official correspondence.