Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004034546

FEI Number

3004034546

Entity Name

A & I INDUSTRIES LTD

City/State/Country

FOSHAN CITY Guangdong, CN

Establishment Address

LIAN DU INDUSTRY PARK, LE LIU TOWN, SHUNDE DISTRICT, FOSHAN 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

Guardian TECH MED Medline Drive Hugo Airgo Alevo Knee Walker Medline Drive Breezy Guardian RHYTHM Stella Swivelmate MECHANICAL(MULTIPLE BRANDS) TECH MED cup holder cane holder GF AMG USA Airgo Breezy Drive EVEREST JENNINGS TECH-Med Services Otter Drive Medline Guardian GF LUMEX Medline Drive Drive Guardian Medline TECH MED GF Padded Splint Disposable Splint Waterproof Splint Drive Medline Guardian Ferno 444 Traction Splint Ferno 443 Traction Splint Medline Drive GF Guardian Airgo Drive Medline Industries, Inc. Airgo Drive ARM PAD.DSK-PMT XD (90762911) Breezy Medline GF TECH MED Services EVEREST JENNINGS INSIGNIA Guardian Breezy Drive Mckesson Corp./Cypress Medical Products Medline TECH-MED SERVICES INC. Medline Industries, Inc. Mckesson Corp./Cypress Medical Products Drive Guardian Medline Drive TECH MED Drive Medline Guardian Medline Industries, Inc. Drive Medline Guardian GF TECH MED Drive Medline Drive Medline Guardian wheelchair foundation strongback mobility struck transport strongback mobility struck 24 Drive Breezy Airgo Mckesson Corp. Cypress Medical Products EVEREST JENNINGS TECH-Med Services Gazelle Titan Ferno 65 Scoop Drive Breezy EVEREST JENNINGS Airgo Breezy EVEREST JENNINGS TECH-Med Services Medline Industries, Inc. Medline Revolution Mobility Drive Guardian Airgo Medline Breezy Stella EVEREST JENNINGS INSIGNIA Drive TECH MED Servcies ELEVATING LEGREST,COMPLETE PMT XD (90762919) Guardian Ivel cargo & Parts Mayo Stand Guardian Medline Drive Drive Breezy Medline TECH MED Guardian GF

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FML	Chair, Blood Donor	General Hospital	Class 1	880.6140	2007-05-04
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2002-03-27
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2004-10-14
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2004-10-14
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2004-11-05
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2004-10-14
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2011-01-14
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2008-05-21
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2004-10-14
IML	Armrest, Wheelchair	Physical Medicine	Class 1	890.3920	2004-10-14
IMW	Brake, Extension, Wheelchair	Physical Medicine	Class 1	890.3920	2003-01-31
IPR	Crutch	Physical Medicine	Class 1	890.3150	2004-10-14
HSS	Halter, Head, Traction	Orthopedic	Class 1	888.5890	2006-08-25
KHY	Cane, Safety Walk	Physical Medicine	Class 1	890.3075	2004-10-14
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2004-10-14
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2009-05-29
FZK	Chair, Surgical, Non-Electrical	General, Plastic Surgery	Class 1	878.4950	2009-05-27
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2007-11-04
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2004-10-14
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2012-07-30
IQB	Belt, Wheelchair	Physical Medicine	Class 1	890.3920	2004-10-14
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2004-10-14
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2004-10-14
IMM	Footrest, Wheelchair	Physical Medicine	Class 1	890.3920	2004-10-14
FRJ	Chair, Geriatric	General Hospital	Class 1	880.6140	2012-12-06
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2009-05-27
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2004-10-14

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
3021327432	FA HORN TRADING INCORPORATED COMPANY	JIAYI COUNTY Chiayi (City), TW
3014273557	CC HSING COMPANY LIMITED	Xikou Township Chiayi, TW

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-0037-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0038-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018	Handicare AB Maskinvagen	1	Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004034546. Last updated year: 2026. Please use registration number 3004034546 when referencing this establishment in official correspondence.