Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006534178

FEI Number

3006534178

Entity Name

DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD

City/State/Country

DANYANG Jiangsu, CN

Establishment Address

NO.1 ZHENXING RD, YUNYANG, ECONOMICAL DEVELOPMENT ZONE, DANYANG Jiangsu 212300, CN

Establishment Type(s)

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

Owner / Operator

Danyang Huayi Medical Supply & Equipment Co, Ltd. (Owner Number: 9099959)

Owner / Operator Contact Address

No. 1 Zhenxing Rd., Yunyang Economical, Development Zone, Danyang, CN-JS 212300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Knee walker Commode Chair

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2009-07-30
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2021-03-23
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2008-02-22
IMM	Footrest, Wheelchair	Physical Medicine	Class 1	890.3920	2007-04-04
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2008-11-21
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2010-01-15
FRJ	Chair, Geriatric	General Hospital	Class 1	880.6140	2019-03-22
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2017-05-17

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

Danyang Huayi Medical Supply & Equipment 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
K935211	Brookefield Hunter, Inc.	WALK N CHAIR	1994-02-02
K832685	Health America	WHEELCHAIR-VARIOUS MODELS	1983-09-20
K003939	Invacare Corp.	VENTURE HOME FILL II, MODEL IOH 200	2001-03-21
K942357	Healthdyne, Inc.	H-500 ALLIANCE OXYGEN CONCENTRATOR	1994-05-27
K042262	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10	2004-09-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2007	Sunrise Medical	2	DeVilbiss iFill Personal Oxygen Station model number 535D.
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.

Similar Registrations

Registration Number	Establishment Name	Location
3015772781	Drive DeVilbiss Healthcare	Palmetto, GA, US
1058397	NEIL MEDICAL GROUP	Kinston, NC, US
1531186	INVACARE CORP. DBA INVACARE AMERICA	ELYRIA, OH, US
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 3006534178. Last updated year: 2026. Please use registration number 3006534178 when referencing this establishment in official correspondence.