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Aikin Healthcare Co., LTD: FDA-registered device maker in Kunshan Jiangsu, China, 1 510(k) clearance

Name: Aikin Healthcare Co., LTD FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Aikin Healthcare Co., LTD is registered with the FDA (registration 3007499787) in Kunshan Jiangsu, China. It lists 21 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 13, 2012. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007499787
Address: 178 Kang Zhuang Rd. Zhou Shi Zhen, Kunshan Jiangsu, China, 215314
Owner or operator: AHT Enterprise Corporation (10085047)
Roles: Contract manufacturer, Manufacturer
First device listed: April 28, 2022
Registered through: 2026
Brand names listed: ACCESSORIES, WHEELCHAIR, OXYGEN HOLDER, CANE & CRUTCH HOLDER (PLASTIC) tray table of wheelchair, ADAPTOR, HYGIENE, TOILET SEAT, TOILET SAFETY FRAME, AID, TRANSFER , BATH BENCH, SHOWER CHAIR, FOOT STOOL TUB RALL, GRAB BAR, ARMREST, WHEELCHAIR, ATTACHMENT, COMMODE, WHEELCHAIR, BRAKE, EXTENSION, WHEELCHAIR, CANE, CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT), E-RACK, OXYGEN CART, OXYGEN BAG, NEBULIZER BAG and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Wheelchair	KNO	1	Manufacturer	accessdata.fda.gov
Adaptor, Hygiene	ILS	1	Manufacturer	accessdata.fda.gov
Aid, Transfer	IKX	1	Manufacturer	accessdata.fda.gov
Armrest, Wheelchair	IML	1	Manufacturer	accessdata.fda.gov
Attachment, Commode, Wheelchair	INB	1	Manufacturer	accessdata.fda.gov
Belt, Wheelchair	IQB	1	Manufacturer	accessdata.fda.gov
Board, Lap, Wheelchair	IMX	1	Contract manufacturer	accessdata.fda.gov
Brake, Extension, Wheelchair	IMW	1	Manufacturer	accessdata.fda.gov
Cane	IPS	1	Manufacturer	accessdata.fda.gov
Cart, Emergency, Cardiopulmonary (Excluding Equipment)	BZN	1	Manufacturer	accessdata.fda.gov
Chair, Adjustable, Mechanical	INN	1	Manufacturer	accessdata.fda.gov
Components, Wheelchair	KNN	1	Manufacturer	accessdata.fda.gov
Crutch	IPR	1	Manufacturer	accessdata.fda.gov
Device, Anti-Tip, Wheelchair	IMR	1	Manufacturer	accessdata.fda.gov
Exerciser, Non-Measuring	ION	1	Manufacturer	accessdata.fda.gov
Footrest, Wheelchair	IMM	1	Manufacturer	accessdata.fda.gov
Handrim, Wheelchair	IMO	1	Manufacturer	accessdata.fda.gov
Stand, Infusion	FOX	1	Manufacturer	accessdata.fda.gov
Table, Mechanical	INW	1	Manufacturer	accessdata.fda.gov
Walker, Mechanical	ITJ	1	Manufacturer	accessdata.fda.gov
Wheelchair, Mechanical	IOR	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 13, 2012	K120032	MECHANICAL WHEELCHAIR	IOR	Substantially Equivalent	Aikin Healthcare Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 13, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.