Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009265647

FEI Number

3009265647

Entity Name

Kunshan Hi-Fortune Health Products Co., Ltd.

City/State/Country

Kunshan City, Jiangsu, CN

Establishment Address

NO.625 Juxiang Road, Zhangpu Town, Kunshan City, Jiangsu 215321, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Kunshan Hi-Fortune Health Products Co., Ltd. (Owner Number: 10036888)

Owner / Operator Contact Address

NO.625 Juxiang Road, Zhangpu Town, Kunshan City, CN-JS 215321, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pride Mobility Products Corp 1450 Electrically Powered Wheelchair 4 FRONT HD, 4 FRONT 2, 4 FRONT, PRIDE, Jazzy EVO 613 AIR Electrically powered wheelchair Adjustable mattress lift belt Wobble board (23301) Rocker board (23300 Pridemobility Pride Mobility Products Corp Pride Mobility Products Corp PRIDE REVO S67 BAJA BANDIT Pride Mobility Products Corp patient lift--HY108 adn HY101-01A HY201 HY601 HY603 WHILL Model C2 Manual wheelchair accessary(Footrest) Pride Mobility Products Corp PrideMobility HP358EA Electrically Powered Wheelchair Scooter Model R Pride Mobility Products Corp Pride Mobility Products Corp Pride Mobility Products Corp Electrically Powered Wheelchair (HP206) Pride Mobility Products Corp Electrically powered wheelchair (HP202) MEDICAL DEPOT d/b/a Drive DeVilbiss Healthcare Pride Mobility Products Corp Pride Mobility Products Corp PRIDE REVO S66 Pride Mobility Products Corp GoGo Super Portable Ceiling hoist-CH100 Pride Mobility Products Corp NIP ROLLATOR Electrically Powered Wheelchair -Model HP358E Pride Mobility Products Corp Mechanical Wheelchair Kunshan Hi-Fortune Health Products Co.,Ltd Toilet lift seat-TLS200 Electric Patient Lift HY108 HY201 Hydraulic Patient Lift HY106 Electric Wheelchair Stylus Litestream XF HD Stylus LS Litestream 500E/Litestream XF PRIDE, R-TRAK, JAZZY ULTRA LIGHT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2015-02-28
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2025-03-21
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2018-01-11
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2024-11-08
LLI	Bed, Therapeutic, Ac-Powered, Adjustable Home-Use	General Hospital	Class 2	880.5100	2015-04-13
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2021-03-03
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2012-11-22
PCD	Powered Stairway Chair Lift	Physical Medicine	Class 2	890.5150	2018-12-13
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2012-08-20
IQB	Belt, Wheelchair	Physical Medicine	Class 1	890.3920	2012-08-20
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2018-01-09
KNL	Board, Scooter, Prone	Physical Medicine	Class 1	890.5370	2012-08-20
FRZ	Device, Patient Transfer, Powered	General Hospital	Class 2	880.6775	2017-02-13
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2021-11-15
IMM	Footrest, Wheelchair	Physical Medicine	Class 1	890.3920	2012-08-22
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2018-11-01
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2022-01-11
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2025-01-16
KID	Restraint, Wheelchair, Non-Protective	Physical Medicine	Class 1	890.3910	2012-08-20
INA	Hill Holder, Wheelchair	Physical Medicine	Class 1	890.3920	2012-08-20
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2012-08-20
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2025-03-21
IMZ	Holder, Crutch And Cane, Wheelchair	Physical Medicine	Class 1	890.3910	2012-08-20
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2024-11-08
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2012-08-20
IMW	Brake, Extension, Wheelchair	Physical Medicine	Class 1	890.3920	2012-08-20
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2018-01-09
IMS	Support, Head And Trunk, Wheelchair	Physical Medicine	Class 1	890.3910	2012-08-20
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2025-12-02
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2020-07-13
IMO	Handrim, Wheelchair	Physical Medicine	Class 1	890.3920	2012-08-20
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2017-03-06
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2021-10-26
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2012-08-20
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2017-07-31
FNG	Lift, Patient, Ac-Powered	General Hospital	Class 2	880.5500	2017-04-20
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2024-11-21
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2011-06-03
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2018-01-11

Official Correspondent

hongfa zhi

US Agent Details

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

Related Public Records

Same Entity

Kunshan Hi-Fortune Health Products 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
K935211	Brookefield Hunter, Inc.	WALK N CHAIR	1994-02-02
K832685	Health America	WHEELCHAIR-VARIOUS MODELS	1983-09-20
K912769	Century Manufacturing Co.	PATIENT LIFT AND TRANSPORT	1991-10-02

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.
Z-0036-2007	Medline Industries Inc	2	Medline Strider Maxi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807600 - red and MDS807600B - blue

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 3009265647. Last updated year: 2026. Please use registration number 3009265647 when referencing this establishment in official correspondence.