Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004194020

FEI Number

3004194020

Entity Name

FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY(LTD)

City/State/Country

FOSHAN Guangdong, CN

Establishment Address

NO.5 XINGFU RD., NANHAI SHISAN INDUSTRIAL PARK, FOSHAN Guangdong 528225, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY(LTD) (Owner Number: 9059383)

Owner / Operator Contact Address

NO.5 XINGFU RD., NANHAI SHISAN INDUSTRIAL PARK, FOSHAN, CN-GD 528225, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MEDICAL TABLE, FS5621 IV STAND MECHANICAL WHEELCHAIR ATTACHMENT, COMMODE, WHEELCHAIR Manual Hospital Bed TIPS AND PADS, CANE, CRUTCH AND WALKER MECHANICAL TABLE Patient Lift MECHANICAL WALKER Mattress ELECTRIC BEDS CRUTCH BATH BENCH ; COMMODE CANE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2014-10-27
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2024-09-30
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2008-03-04
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2011-01-14
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2014-02-16
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2009-04-23
INW	Table, Mechanical	Physical Medicine	Class 1	890.3750	2011-01-14
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2014-05-15
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2003-10-29
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2014-05-15
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2014-02-24
IPR	Crutch	Physical Medicine	Class 1	890.3150	2003-10-29
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2008-09-24
IPS	Cane	Physical Medicine	Class 1	890.3075	2009-04-23

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY(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
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018	Handicare AB Maskinvagen	1	Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
Z-0016-2007	Sunrise Medical CCG, Inc.	2	Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
Z-0017-2007	Hill-Rom, Inc.	2	Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200.
Z-0019-2015	Arjo Hospital Equipment AB Verkstadsvagen	2	ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.

Similar Registrations

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2242467	HAUSMANN ENTERPRISES, LLC	NORTHVALE, NJ, US
1063324	REACT Innovations	Charlotte, NC, US
3043460907	Drive DeVilbiss Healthcare	Perris, CA, US
3005214422	HOMECARE ENTERPRISE CO., LTD.	Changhua City, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004194020. Last updated year: 2026. Please use registration number 3004194020 when referencing this establishment in official correspondence.