Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007499787

FEI Number

3007499787

Entity Name

Aikin Healthcare Co., LTD

City/State/Country

Kunshan Jiangsu, CN

Establishment Address

178 Kang Zhuang Rd., Zhou Shi Zhen, Kunshan Jiangsu 215314, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AHT Enterprise Corporation (Owner Number: 10085047)

Owner / Operator Contact Address

Vistra Corporate Services Centre, G/Floor NPF Building Beach Rd, Apia, WS-TU 96799, WS

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

WALKER, MECHANICAL ROLLATOR, WALKER WHEEL ATTACHMENT, COMMODE, WHEELCHAIR CHAIR, ADJUSTABLE, MECHANICAL ACCESSORIES, WHEELCHAIR, OXYGEN HOLDER, CANE & CRUTCH HOLDER (PLASTIC) tray table of wheelchair Exerciser, Non-measuring Manual Pedal Exerciser CANE ARMREST, WHEELCHAIR HANDRIM, WHEELCHAIR CRUTCH BRAKE, EXTENSION, WHEELCHAIR FOOTREST, WHEELCHAIR CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT), E-RACK, OXYGEN CART, OXYGEN BAG, NEBULIZER BAG STAND, INFUSION , IV POLE WHEELCHAIR, MECHANICAL DEVICE, ANTI-TIP, WHEELCHAIR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2022-06-23
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2022-06-23
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2022-06-23
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2022-06-23
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2022-04-28
IPS	Cane	Physical Medicine	Class 1	890.3075	2022-06-23
IML	Armrest, Wheelchair	Physical Medicine	Class 1	890.3920	2022-06-23
IMO	Handrim, Wheelchair	Physical Medicine	Class 1	890.3920	2022-06-23
IPR	Crutch	Physical Medicine	Class 1	890.3150	2022-06-23
IMW	Brake, Extension, Wheelchair	Physical Medicine	Class 1	890.3920	2022-06-23
IMM	Footrest, Wheelchair	Physical Medicine	Class 1	890.3920	2022-06-23
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2022-06-23
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2022-06-23
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2022-06-23
IMR	Device, Anti-Tip, Wheelchair	Physical Medicine	Class 1	890.3920	2022-06-23

Official Correspondent

Shun-Hui Fan

US Agent Details

Kevin Walls Business: Regulatory Insight, Inc. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

AHT Enterprise Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3023189540	AHT ENTERPRISE CORPORATION	Hsinchu, TW

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935211	Brookefield Hunter, Inc.	WALK N CHAIR	1994-02-02
K832685	Health America	WHEELCHAIR-VARIOUS MODELS	1983-09-20

Similar Registrations

Registration Number	Establishment Name	Location
3014336266	SUZHOU HY MEDICAL TRADING CO., LTD	Taicang Jiangsu, CN
3027498086	CHARMING WORLD INC.	Taipei City, TW
3039346864	FIRST NATION GROUP, LLC	Niceville, FL, US
3029740428	ORA MEDICAL INC	Montreal Quebec, CA
3014214233	CORE MOBILITY SOLUTIONS	Los Gatos, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007499787. Last updated year: 2026. Please use registration number 3007499787 when referencing this establishment in official correspondence.