Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013495708

FEI Number

3013495708

Entity Name

ZHONG SHAN LEBO MEDICAL COMPANY LIMITED

City/State/Country

Zhongshan City Guangdong, CN

Establishment Address

A1 first floor and 8th floor, Building 4, No. 1, Taiye Road, Baofeng Community, Xiaolan Town, Zhongshan City Guangdong 528414, CN

Establishment Type(s)

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

Owner / Operator

ZHONG SHAN LEBO MEDICAL COMPANY LIMITED (Owner Number: 10054750)

Owner / Operator Contact Address

A1 first floor and 8th floor, Building 4, No. 1, Taiye Road, Baofeng Community, Xiaolan 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

Cane Urinal bottle Walker and Rollator Transfer board Crutch IV Stand Safety Bar, Commode Chair, Shower Bench, Bed Rail Transport Chair Safety Walk Cane Heel pillow,Side pillow Nasal Rinse Bottle Wheelchair Accessories(Wheelchair cushion) Mechanical Bed

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPS	Cane	Physical Medicine	Class 1	890.3075	2017-04-22
FNP	Urinal	General Hospital	Class 1	880.6730	2021-12-13
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2017-04-22
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2023-10-31
IPR	Crutch	Physical Medicine	Class 1	890.3150	2017-04-22
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2017-04-22
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2017-04-22
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2017-04-22
KHY	Cane, Safety Walk	Physical Medicine	Class 1	890.3075	2017-04-22
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2021-04-05
KAR	Irrigator, Sinus	Ear, Nose, Throat	Class 1	874.4420	2025-03-12
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2021-07-12
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2017-04-22

Official Correspondent

Yu Chen

US Agent Details

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

Related Public Records

Same Entity

ZHONG SHAN LEBO MEDICAL COMPANY LIMITED

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

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

Registration Number	Establishment Name	Location
3017496567	ALIGNED AS DESIGNED, LLC	Pasadena, CA, US
8043549	HMS-VILGO	BERGERAC, CEDEX Dordogne, FR
3034731542	GUANCHI TECHNOLOGY (HEBEI) CO., LTD.	Hengshui Hebei, CN
3016678414	FOSHAN FEIYANG MEDICAL EQUIPMENT CO., LTD.	Foshan Guangdong, CN
1422443	DMS HOLDINGS, INC.,	Waukegan, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013495708. Last updated year: 2026. Please use registration number 3013495708 when referencing this establishment in official correspondence.