Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021327432

FEI Number

3021327432

Entity Name

FA HORN TRADING INCORPORATED COMPANY

City/State/Country

JIAYI COUNTY Chiayi (City), TW

Establishment Address

No. 1, BENTING, BENCUO VILLAGE, XIKOU TOWNSHIP, JIAYI COUNTY Chiayi (City) 62348, TW

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

Otter Drive Medline Guardian GF wheelchair foundation strongback mobility struck transport strongback mobility struck 24 Drive Breezy Hugo Airgo Alevo Knee Walker Medline Drive Breezy Guardian RHYTHM Stella Swivelmate MECHANICAL(MULTIPLE BRANDS) TECH MED cup holder cane holder GF AMG USA Drive Barton Medical Corporation Rhythm Healthcare LLC Airgo Trust Worth Hugo Breezy STRIVE stroller INSIGNIA Drive AMG USA Transport chair Medline Guardian TECH MED Services

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2004-10-14
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2007-11-04
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2002-03-27
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2004-10-14
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2004-03-10

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
3004443928	ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.	GUANGDONG, CN
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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
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 3021327432. Last updated year: 2026. Please use registration number 3021327432 when referencing this establishment in official correspondence.