Data / Medical devices / China / Jiangsu Suntec Medical Technology Co., Ltd.

Jiangsu Suntec Medical Technology Co., Ltd.: FDA-registered device maker in Jiepai Danyang Jiangsu, China, 1 510(k) clearance

Name: Jiangsu Suntec Medical Technology Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Jiangsu Suntec Medical Technology Co., Ltd. is registered with the FDA (registration 3011475060) in Jiepai Danyang Jiangsu, China. It lists 14 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 3, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011475060
Address: Jiepai Industrial Zone, Jiepai Danyang Jiangsu, China, 212300
Owner or operator: Jiangsu Suntec Medical Technology Co., Ltd. (10048106)
Roles: Exporter to the US, Manufacturer
First device listed: December 8, 2014
Registered through: 2026
Brand names listed: Bath Chair, Caster with Chair, Commode, Emergency Cart, Infusion Stand, Knee Walker, Walker, Rollator, SUNTEC Mechanical Wheelchair, model ST-WL-1000, Transfer Aid and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Wheelchair	KNO	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Adaptor, Hygiene	ILS	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Aid, Transfer	IKX	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Attachment, Commode, Wheelchair	INB	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Belt, Wheelchair	IQB	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Brake, Extension, Wheelchair	IMW	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Cart, Emergency, Cardiopulmonary (Excluding Equipment)	BZN	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Chair, With Casters	INM	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Components, Wheelchair	KNN	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Cushion, Wheelchair	IMP	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Device, Anti-Tip, Wheelchair	IMR	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Stand, Infusion	FOX	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Walker, Mechanical	ITJ	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Wheelchair, Mechanical	IOR	1	Exporter to the US, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 3, 2016	K152878	SUNTEC Mechanical Wheelchair, model ST-WL-1000	IOR	Substantially Equivalent	Danyang Suntec Auto Parts Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated February 3, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.