Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007309323

FEI Number

3007309323

Entity Name

ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD

City/State/Country

ZHENJIANG CITY Jiangsu, CN

Establishment Address

No.297/799, Chuqiao road, NO.39, Hengtong Road, ZHENJIANG CITY Jiangsu 212009, CN

Establishment Type(s)

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

Owner / Operator

ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD (Owner Number: 10027294)

Owner / Operator Contact Address

#297 CHUQIAO ROAD, ZHENJIANG CITY, CN-JS 212000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

guardian pediatric wheelchair Medline Industries, LP Medline Industries, LP K5 Guardian wheelchair,MEDLINE wheelchair,Mechanical Medline Industries, LP Medical Depot Inc Medline Industries, LP Medline Industries, LP Medical Depot Inc POWER WHEELCHAIR EL-001 Medline Industries, LP Medical Depot Inc Medical Depot Inc

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2025-11-26
IMM	Footrest, Wheelchair	Physical Medicine	Class 1	890.3920	2008-12-17
INW	Table, Mechanical	Physical Medicine	Class 1	890.3750	2017-04-09
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2025-11-28
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2026-04-14
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2008-10-21
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2012-03-04
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2008-10-21
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2008-10-21
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2021-08-31
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2023-09-27
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2025-05-06
IML	Armrest, Wheelchair	Physical Medicine	Class 1	890.3920	2008-12-17
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2008-10-21
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2012-05-09
KID	Restraint, Wheelchair, Non-Protective	Physical Medicine	Class 1	890.3910	2024-06-06
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2008-12-17
IMR	Device, Anti-Tip, Wheelchair	Physical Medicine	Class 1	890.3920	2008-10-21
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2026-04-14
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2023-09-27
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2017-04-25
IMW	Brake, Extension, Wheelchair	Physical Medicine	Class 1	890.3920	2022-12-27

Official Correspondent

BRUCE XIE

US Agent Details

ALEX HORNG Email: karmanhc@yahoo.com Phone: (626) 3788058

Related Public Records

Same Entity

ZHENJIANG ASSURE 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
K935211	Brookefield Hunter, Inc.	WALK N CHAIR	1994-02-02
K832685	Health America	WHEELCHAIR-VARIOUS MODELS	1983-09-20
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K853594	Vessa , Ltd.	VESSA FLIVVA	1985-09-24
K142783	Heartway Medical Products Co., Ltd.	HEARTWAY Electrically Powered Wheelchair P27	2015-06-12

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
Z-0005-2018	Permobil, Ab Arvaltsvagen 10	2	Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
Z-0006-2018	Permobil, Ab Arvaltsvagen 10	2	Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007309323. Last updated year: 2026. Please use registration number 3007309323 when referencing this establishment in official correspondence.