Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017421556

FEI Number

3017421556

Entity Name

ZHANGJIAGANG HERUI MEDICAL EQUIPMENT CO.,LTD.

City/State/Country

ZhangJiaGang City Jiangsu, CN

Establishment Address

1F/2F/3F Workshop 15, No.2258, SanXing WuKeSong Road, JinFeng Town, ZhangJiaGang City Jiangsu 215624, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ZhangJiaGang HeRui Medical Equipment Co.,Ltd. (Owner Number: 10076141)

Owner / Operator Contact Address

1F/2F/3F Workshop 15, No.2258, SanXing WuKeSong Road, JinFeng Town, ZhangJiaGang City, CN-JS 215624, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cervical Collars , ExtricationDevice , Head Immobilizer Wheeled Stretcher, Stair Chair Stretcher, Patient Restraint Ambulance Stretcher, Spade Stretcher Multifunction chair,Lift Transfer Chair,Commode chair Connecting trolley; EmergencyTrolley , ABS Cart

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2020-09-09
FPO	Stretcher, Wheeled	General Hospital	Class 2	880.6910	2020-07-08
NZD	Stretcher, Patient Restraint	General Hospital	Class 1	880.6900	2020-07-08
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2020-07-08
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2021-11-28
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2020-09-09

Official Correspondent

Tong De Xu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

ZhangJiaGang HeRui Medical Equipment 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-0023-05	Stryker Medical	2	Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.
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 3017421556. Last updated year: 2026. Please use registration number 3017421556 when referencing this establishment in official correspondence.