Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022136917

FEI Number

3022136917

Entity Name

GUANGDONG ROADMATE GROUP CO. LTD

City/State/Country

ZHONGSHAN CITY Guangdong, CN

Establishment Address

NO. 16 YONGYI 6TH ROAD, HENGLAN TOWN, ZHONGSHAN CITY Guangdong 528478, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

GUANGDONG ROADMATE GROUP CO. LTD (Owner Number: 10095372)

Owner / Operator Contact Address

NO. 16 YONGYI 6TH ROAD, HENGLAN TOWN, ZHONGSHAN CITY, CN-GD 528478, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Maclaren Maclaren Major Elite

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2026-03-04

Official Correspondent

Mark Scott

US Agent Details

Mark Scott Business: Coche Mobility Solutions Email: mark.scott@cochestroller.com Phone: (678) 3725205

Related Public Records

Same Entity

GUANGDONG ROADMATE GROUP CO. LTD

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

View Entity Profile →

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
3013541941	VIETNAM PRECISION INDUSTRIAL NO.1 CO., LTD.	VINH YEN Vinh Phuc, VN
3030690187	Coche Mobility Solutions Inc	Gainesville, GA, US
2183887	EZ WAY, INC.	CLARINDA, IA, US
3005260401	Jiangsu Intco Medical Products Co., Ltd.	Zhenjiang New District Jiangsu, CN
3031284260	FOSHAN OST MEDICAL EQUIPMENT TECHNOLOGY CO., LTD	Foshan Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022136917. Last updated year: 2026. Please use registration number 3022136917 when referencing this establishment in official correspondence.