Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004443928

FEI Number

3004443928

Entity Name

ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.

City/State/Country

GUANGDONG, CN

Establishment Address

3 SHENGHUI SOUTH ROAD, NANTOU TOWN, ZHONGSHAN CITY, GUANGDONG --, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TAIWAN AN I CO.,LTD. (Owner Number: 9021165)

Owner / Operator Contact Address

NO.1 BEEN TING BEEN-TSUOH, VILLAGE, SHI-KOOU SHIANG, CHIA-YI SHIANN, TW-NOTA --, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

JOHN BUNN Padded Splint Disposable Splint Waterproof Splint Drive Medline Guardian Ferno 444 Traction Splint Ferno 443 Traction Splint Airgo Trust Worth Hugo Breezy STRIVE stroller INSIGNIA Drive AMG USA Transport chair Medline Guardian TECH MED Services Fusion Sparky Drive Medline Guardian EVEREST JENNINGS drive TM Feather Gazelle Titan Ferno 65 Scoop

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2014-04-08
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2011-01-14
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2004-03-10
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2007-11-04
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2012-07-30

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: REGULATORY INSIGHT, INC. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

TAIWAN AN I CO.,LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1000292485	CHANG CHENG FA ENTERPRISE CO., LIMITED	SHI-KOOU SHIANG Chiayi, TW
3021327432	FA HORN TRADING INCORPORATED COMPANY	JIAYI COUNTY Chiayi (City), TW
3014273557	CC HSING COMPANY LIMITED	Xikou Township Chiayi, TW
3004034546	A & I INDUSTRIES LTD	FOSHAN CITY Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
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 3004443928. Last updated year: 2026. Please use registration number 3004443928 when referencing this establishment in official correspondence.