Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011475060

FEI Number

3011475060

Entity Name

Jiangsu Suntec Medical Technology Co., Ltd.

City/State/Country

Jiepai Danyang Jiangsu, CN

Establishment Address

Jiepai Industrial Zone, Jiepai Danyang Jiangsu 212300, CN

Establishment Type(s)

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

Owner / Operator

Jiangsu Suntec Medical Technology Co., Ltd. (Owner Number: 10048106)

Owner / Operator Contact Address

Jiepai Industrial Zone, Jiepai Danyang, CN-JS 212300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wheelchair Extension Brake SUNTEC Mechanical Wheelchair, model ST-WL-1000 Wheelchair Belt Wheelchair Anti-Tip Caster with Chair Knee Walker, Walker, Rollator Transfer Aid Emergency Cart Wheelchair Cushion Commode

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMW	Brake, Extension, Wheelchair	Physical Medicine	Class 1	890.3920	2014-12-08
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2016-02-14
IQB	Belt, Wheelchair	Physical Medicine	Class 1	890.3920	2024-01-31
IMR	Device, Anti-Tip, Wheelchair	Physical Medicine	Class 1	890.3920	2014-12-08
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2014-12-08
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2019-08-22
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2025-06-12
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2024-06-25
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2014-12-08
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2014-12-08

Official Correspondent

No official correspondent registered.

US Agent Details

Shu-Chen Cheng Business: ROC Chinese-European Industrial Research Society Email: ceirs.jen@msa.hinet.net Phone: (614) 5888168

Related Public Records

Same Entity

Jiangsu Suntec Medical Technology 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

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011475060. Last updated year: 2026. Please use registration number 3011475060 when referencing this establishment in official correspondence.