Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004111085

FEI Number

3004111085

Entity Name

Jiangsu Yuyue Medical Equipment & Supply Company Limited

City/State/Country

JIANGSU, CN

Establishment Address

YUNYANG INDUSTRIAL PARK, DANYANG CITY, JIANGSU 212300, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Jiangsu Yuyue Medical Equipment & Supply Company Limited (Owner Number: 9069200)

Owner / Operator Contact Address

Yunyang Industrial Park, Oversea Dept, Danyang City, CN-JS 212300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wheelchair K7 Wheelchair K2 Wheechair PC008 Wheelchair H035 Wheelchair H005 Cart

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2025-08-12
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2016-07-15
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2016-01-19
INW	Table, Mechanical	Physical Medicine	Class 1	890.3750	2006-02-27
IMM	Footrest, Wheelchair	Physical Medicine	Class 1	890.3920	2013-03-19
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2004-12-28
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2025-08-12
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2025-08-12
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2016-06-03
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2020-03-13

Official Correspondent

No official correspondent registered.

US Agent Details

Fang(Fawn) Zhang Business: Yuwell MedTech USA LLC Email: fawn.zhang@yuwell.com Phone: (206) 6391311

Related Public Records

Same Entity

Jiangsu Yuyue Medical Equipment & Supply Company Limited

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
K935211	Brookefield Hunter, Inc.	WALK N CHAIR	1994-02-02
K832685	Health America	WHEELCHAIR-VARIOUS MODELS	1983-09-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0037-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0038-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.

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3001657382	R82 A/S	GEDVED Midtjylland, DK
2131358	BRUNO INDEPENDENT LIVING AIDS, INC.	OCONOMOWOC, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004111085. Last updated year: 2026. Please use registration number 3004111085 when referencing this establishment in official correspondence.