Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032171348

FEI Number

3032171348

Entity Name

IF HEALTH (XIAMEN) INTELLIGENT TECHNOLOGY CO.,LTD

City/State/Country

Xiamen Fujian, CN

Establishment Address

Zone A, 4th Floor, No.3 Building, No.66, xiangyue Rd, Torch High-tech Zone (Xiang'an) Industrial Zone,, Xiamen Fujian 361115, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

IF Health (Xiamen) Intelligent Technology Co.,Ltd (Owner Number: 10091119)

Owner / Operator Contact Address

Zone A, 4th Floor, No.3 Building, No.66, xiangyue Rd, Torch High-tech Zone (Xiang'an) Industrial Zone,, Xiamen, CN-FJ 361115, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241154

PMA Number

N/A

All Registered Proprietary Names

Electric Wheelchair

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2024-07-07

Official Correspondent

Xiang Gao

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

IF Health (Xiamen) Intelligent Technology Co.,Ltd

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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-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
Z-0039-2007	Eagle Parts and Products	2	Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel mount motors.
Z-0040-2007	Eagle Parts and Products	2	Eagle Parts and Products Model 624Mini Power Wheel Chairs with internally threaded wheel mount motors.

Similar Registrations

Registration Number	Establishment Name	Location
3045076265	BEIJING ORIONSTAR TECHNOLOGY CO., LTD.	Beijing, CN
3006160539	LOH ENTERPRISES, LLC	Clarks Summit, PA, US
3002667030	TUNG KENG ENTERPRISE CO., LTD.	Taichung City, TW
3043165991	HEBEI DANSONG MEDICAL TECHNOLOGY CO., LTD.	SHIJIAZHUANG Hebei, CN
3036988603	SHENZHEN YATTLL INDUSTRY CO., LTD	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032171348. Last updated year: 2026. Please use registration number 3032171348 when referencing this establishment in official correspondence.