Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011574775

FEI Number

3011574775

Entity Name

GUANGDONG KAREWAY MEDICAL TECHNOLOGY CO., LTD

City/State/Country

Foshan Guangdong, CN

Establishment Address

One of No.19 Jinshi Avenue, Nanhai National Eco-industrial Demonstration Zone, Danzao Town, Nanhai Distirct, Foshan Guangdong 528200, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guangdong Kareway Medical Technology Co., Ltd (Owner Number: 10057181)

Owner / Operator Contact Address

One of No.19 Jinshi Avenue, Nanhai National Eco-industrial Demonstration Zone, Danzao Town, Nanhai Distirct, Foshan, CN-GD 528200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Commode Chair Shower Chair RAISED TOILET SEAT WHEELED STRETCHER MATTRESS MANUAL OPERATION TABLE TROLLEY, Exam Stool, Blood Drawing Chair, Dining Table, Recliner Chair Electric Hospital Bed Electric Chair

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2018-03-05
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2018-03-05
FPO	Stretcher, Wheeled	General Hospital	Class 2	880.6910	2019-01-27
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2019-01-27
FSE	Table, Operating-Room, Manual	General, Plastic Surgery	Class 1	878.4950	2019-01-27
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2019-01-27
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2018-03-05
INO	Chair, Positioning, Electric	Physical Medicine	Class 2	890.3110	2025-09-01

Official Correspondent

Zehong Lu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Guangdong Kareway Medical Technology 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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-05	Stryker Medical	2	Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.
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

Similar Registrations

Registration Number	Establishment Name	Location
3030976037	CLARION CARE LLC	Valdosta, GA, US
3008881803	PT. MEGA ANDALAN KALASAN	JOGYAKARTA Yogyakarta, ID
3012316249	COMPASS HEALTH BRANDS (CORPORATE OFFICE)	Middleburg Heights, OH, US
3010785927	HENGSHUI RUNDE MEDICAL INSTRUMENTS CO.,LTD	Hengshui City Hebei, CN
3012579728	FOSHAN HUAFUKANG MEDICAL TECHNOLOGY CO. LTD	Foshan City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011574775. Last updated year: 2026. Please use registration number 3011574775 when referencing this establishment in official correspondence.