Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019502344

FEI Number

3019502344

Entity Name

FOSHAN MAIKANG MEDICAL EQUIPMENT CO., LTD

City/State/Country

Foshan Guangdong, CN

Establishment Address

Block C, No.1 Keji 4th Road, Xintan town, Shunde District, Foshan Guangdong 528000, CN

Establishment Type(s)

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

Owner / Operator

Foshan MaiKang Medical Equipment Co., Ltd (Owner Number: 10081907)

Owner / Operator Contact Address

Block C, No.1 Keji 4th Road, Xintan town, Shunde District, Foshan, CN-GD 528000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bed Rail; Adaptor; Hygiene - Bath Bench; Commode Chair; Grab Bar; Raised Toilet Seat; Shower Chair; ward screen Bed, Manual - Manual Bed; Pediatric Bed Table And Attachments, Medical Trolly, Over bed table Stand, Infusion - I.V. Stand Tips And Pads, Cane, Crutch And Walker - Tips And Pads,wheels Urine Collection Bag Walker, Mechanical - Walker; Shopping Cart ; Rollator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2021-05-25
FNS	Ring Cutter	General Hospital	Class 1	880.6200	2021-05-25
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2021-05-25
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2021-05-25
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2021-05-25
NZU	Collector, Urine, Powered, Non Indwelling Catheter	Gastroenterology, Urology	Class 1	876.5250	2024-08-05
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2021-05-25

Official Correspondent

Kuang Sun

US Agent Details

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

Related Public Records

Same Entity

Foshan MaiKang 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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2015	Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056	1	Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010.
Z-0031-2013	Winco Mfg., LLC	1	Caremor Cliner"*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 536 Serial No. 536A-101475" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair
Z-0032-2013	Winco Mfg., LLC	1	Caremor Cliner is labeled in part: "*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 535 Serial No. 535A-104522" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair

Similar Registrations

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3043126945	DONGGUAN QIANHE ELECTRONIC TECHNOLOGY CO., LTD.	Dongguan Guangdong, CN
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3004126239	MERCHSOURCE LLC	Irvine, CA, US
3026875457	WUYI FORTUNE-LAND SPORTS AND LEISURE PRODUCTS CO., LTD	Jinhua Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019502344. Last updated year: 2026. Please use registration number 3019502344 when referencing this establishment in official correspondence.