Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007120364

FEI Number

3007120364

Entity Name

Foshan Kaiyang Medical Equipment Co., Ltd.

City/State/Country

Foshan City Guangdong, CN

Establishment Address

3 of No. 21, The 3rd Hongling Road, Shishan Town, Nanhai District, Foshan City Guangdong 528231, CN

Establishment Type(s)

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

Owner / Operator

Foshan Kaiyang Medical Equipment Co., Ltd. (Owner Number: 10026314)

Owner / Operator Contact Address

3 of No. 21, The 3rd Hongling Road, Shishan Town, Nanhai District, Foshan City, CN-GD 528231, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Mechanical Wheelchair Manual Bed Powered Hospital Bed Mechanical Walker Wheelchair Commode Hygiene Products Holder, Crutch and Cane, Wheelchair

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2008-09-09
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2009-08-11
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2009-08-11
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2008-07-02
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2009-08-11
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2009-08-11
IMZ	Holder, Crutch And Cane, Wheelchair	Physical Medicine	Class 1	890.3910	2009-08-11

Official Correspondent

No official correspondent registered.

US Agent Details

Shu-Chen Cheng Business: ROC Chinese-European Industrial Research Society Email: ceirs.jen@msa.hinet.net Phone: (614) 5888168

Related Public Records

Same Entity

Foshan Kaiyang Medical 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
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-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.
Z-0026-2007	Extended Care Air Therapy Systems Inc	2	ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007120364. Last updated year: 2026. Please use registration number 3007120364 when referencing this establishment in official correspondence.