Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043127556

FEI Number

3043127556

Entity Name

COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD.

City/State/Country

Zhongshan City Guangdong, CN

Establishment Address

2F and 3F. No.102, Yulong 3rd Road, Xinsheng Village, Xiaolan Town, Zhongshan City Guangdong 528415, CN

Establishment Type(s)

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

Owner / Operator

COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD. (Owner Number: 10027080)

Owner / Operator Contact Address

No.6 Tongxing East Road, Dongsheng Town, Zhongshan City, CN-GD 528414, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Combo Exerciser COMBO MECHANICAL CHAIR Traction Set and Exercise Pulley Shower Bench & Commode Combo mechanical chair Flip for Cane and Crutch Transfer Aid Tips for Cane and Crutch Bed side rails and fences COMBO QUAD CANE, MULTIPLE Walker & Rollator Bed Assist Bars Overbed Table

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2013-11-01
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2010-07-21
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2015-11-16
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2008-09-25
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2010-07-20
IMZ	Holder, Crutch And Cane, Wheelchair	Physical Medicine	Class 1	890.3910	2015-11-16
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2022-03-18
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2015-10-30
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2018-03-19
KHY	Cane, Safety Walk	Physical Medicine	Class 1	890.3075	2011-05-12
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2008-09-25
QTC	Adult Portable Bed Rails For Medical Purposes	Physical Medicine	Class 1	890.5050	2023-09-05
INW	Table, Mechanical	Physical Medicine	Class 1	890.3750	2009-10-26

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

COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007222468	COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD.	Zhongshan City Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043127556. Last updated year: 2026. Please use registration number 3043127556 when referencing this establishment in official correspondence.