Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033814356

FEI Number

3033814356

Entity Name

JIANGSU ASSURE MEDICAL EQUIPMENT CO., LTD

City/State/Country

ZHENJIANG CITY Jiangsu, CN

Establishment Address

No. 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

JIANGSU ASSURE MEDICAL EQUIPMENT CO LTD (Owner Number: 10091590)

Owner / Operator Contact Address

No. 799, CHUQIAO ROAD, ZHENJIANG CITY, CN-JS 212009, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Safety belt Guardian Reclining wheelchair Medline Industries, LP ASSURE guardian pediatric wheelchair Medline Industries, LP Bariatric Heavy duty wheelchair Reclining wheelchair ASSURE ASSURE Medical Depot Inc ASSURE ASSURE Guardian K3 Wheelchair, Guardian Wheelchair Extra Wide, Guardian K3 Wheelchair Plus, Guardian K4 Wheelchair, Walgreens K ASSURE Medline K5166N21E1 K5166N21S1 K5186N21E1 K5186N21S1 K5206N21E1 K5206N21S1 K5 ASSURE ASSURE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2025-09-03
IQB	Belt, Wheelchair	Physical Medicine	Class 1	890.3920	2026-06-01
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2025-12-13
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2024-10-24
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2025-12-13
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2024-10-24
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2024-10-24
KID	Restraint, Wheelchair, Non-Protective	Physical Medicine	Class 1	890.3910	2024-10-24
IML	Armrest, Wheelchair	Physical Medicine	Class 1	890.3920	2024-10-17
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2025-12-13
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2024-10-24
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2024-10-24
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2024-10-24
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2024-10-24
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2026-04-14
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2024-10-24
IMR	Device, Anti-Tip, Wheelchair	Physical Medicine	Class 1	890.3920	2024-10-24

Official Correspondent

BRUCE XIE

US Agent Details

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

Related Public Records

Same Entity

JIANGSU 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

Similar Registrations

Registration Number	Establishment Name	Location
3015772781	Drive DeVilbiss Healthcare	Palmetto, GA, US
1058397	NEIL MEDICAL GROUP	Kinston, NC, US
1531186	INVACARE CORP. DBA INVACARE AMERICA	ELYRIA, OH, US
3001657382	R82 A/S	GEDVED Midtjylland, DK
2131358	BRUNO INDEPENDENT LIVING AIDS, INC.	OCONOMOWOC, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033814356. Last updated year: 2026. Please use registration number 3033814356 when referencing this establishment in official correspondence.