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Data / Medical devices / China / Kunshan Hi-Fortune Health Products Co., Ltd.

Kunshan Hi-Fortune Health Products Co., Ltd.: FDA-registered device maker in Kunshan City, Jiangsu, China, 14 510(k) clearances

Kunshan Hi-Fortune Health Products Co., Ltd. is registered with the FDA (registration 3009265647) in Kunshan City, Jiangsu, China. It lists 32 device types. The FDA files 14 510(k) clearances under its listings, the newest dated March 26, 2025. Registered through 2027. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Kunshan Hi-Fortune Health Products Co., Ltd.
FDA registration number
3009265647
Address
NO.625 Juxiang Road, Zhangpu Town, Kunshan City, Jiangsu, China, 215321
Owner or operator
Kunshan Hi-Fortune Health Products Co., Ltd. (10036888)
Roles
Contract manufacturer, Manufacturer
First device listed
June 3, 2011
Registered through
2027
Brand names listed
1450, 4 FRONT, 4 FRONT 2, FDW, Jazzy EVO 613 AIR,FrontRunner, Adjustable mattress, BAJA BANDIT, Bariatric Recline Seating system, Ceiling hoist-CH100, Electric Patient Lift HY108, Electric Wheelchair and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, WheelchairKNO1Contract manufactureraccessdata.fda.gov
Armboard, WheelchairIMY1Contract manufactureraccessdata.fda.gov
Armrest, WheelchairIML1Contract manufactureraccessdata.fda.gov
Attachment, Commode, WheelchairINB1Contract manufacturer, Manufactureraccessdata.fda.gov
Bed, Therapeutic, Ac-Powered, Adjustable Home-UseLLI2Manufactureraccessdata.fda.gov
Belt, WheelchairIQB1Contract manufactureraccessdata.fda.gov
Board, Lap, WheelchairIMX1Contract manufactureraccessdata.fda.gov
Board, Scooter, ProneKNL1Contract manufactureraccessdata.fda.gov
Brake, Extension, WheelchairIMW1Contract manufactureraccessdata.fda.gov
Chair, Adjustable, MechanicalINN1Contract manufactureraccessdata.fda.gov
Chair, With CastersINM1Contract manufactureraccessdata.fda.gov
Climber, Curb, WheelchairIMN1Contract manufactureraccessdata.fda.gov
Components, ExerciseIOD1Manufactureraccessdata.fda.gov
Components, WheelchairKNN1Contract manufacturer, Manufactureraccessdata.fda.gov
Cuff, Pusher, WheelchairINC1Contract manufactureraccessdata.fda.gov
Cushion, WheelchairIMP1Contract manufacturer, Manufactureraccessdata.fda.gov
Device, Anti-Tip, WheelchairIMR1Contract manufactureraccessdata.fda.gov
Device, Patient Transfer, PoweredFRZ2Contract manufacturer, Manufactureraccessdata.fda.gov
Footrest, WheelchairIMM1Contract manufacturer, Manufactureraccessdata.fda.gov
Handrim, WheelchairIMO1Contract manufactureraccessdata.fda.gov
Hill Holder, WheelchairINA1Contract manufactureraccessdata.fda.gov
Holder, Crutch And Cane, WheelchairIMZ1Contract manufactureraccessdata.fda.gov
Lift, Patient, Ac-PoweredFNG2Manufactureraccessdata.fda.gov
Lift, Patient, Non-Ac-PoweredFSA1Manufactureraccessdata.fda.gov
Powered Stairway Chair LiftPCD2Contract manufactureraccessdata.fda.gov
Restraint, Wheelchair, Non-ProtectiveKID1Contract manufactureraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Manufactureraccessdata.fda.gov
Support, Head And Trunk, WheelchairIMS1Contract manufactureraccessdata.fda.gov
Vehicle, Motorized 3-WheeledINI2Contract manufacturer, Manufactureraccessdata.fda.gov
Walker, MechanicalITJ1Contract manufacturer, Manufactureraccessdata.fda.gov
Wheelchair, MechanicalIOR1Contract manufacturer, Manufactureraccessdata.fda.gov
Wheelchair, PoweredITI2Contract manufacturer, Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 26, 2025K244003Electrically powered wheelchairITISubstantially EquivalentKunshan Hi-Fortune Health Products Co., Ltd.accessdata.fda.gov
February 12, 2025K243962Electrically Powered WheelchairITISubstantially EquivalentKunshan Hi-Fortune Health Products Co., Ltd.accessdata.fda.gov
February 12, 2025K243961Electrically Powered WheelchairITISubstantially EquivalentKunshan Hi-Fortune Health Products Co., Ltd.accessdata.fda.gov
October 17, 2024K241337Electrically powered wheelchair (HP202)ITISubstantially EquivalentKunshan Hi-Fortune Health Products Co., Ltd.accessdata.fda.gov
October 16, 2024K241632Electrically powered wheelchairITISubstantially EquivalentKunshan Hi-Fortune Health Products Co., Ltd.accessdata.fda.gov
January 18, 2022K212503HP458E Electrically Powered WheelchairITISubstantially EquivalentKunshan Hi-Fortune Health Products Co., Ltd.accessdata.fda.gov
January 4, 2022K211647HP358EA Electrically Powered WheelchairITISubstantially EquivalentKunshan Hi-Fortune Health Products Co., Ltd.accessdata.fda.gov
September 28, 2021K201855Electrically Powered Wheelchair -Model HP358EITISubstantially EquivalentKunshan Hi-Fortune Health Products Co., Ltd.accessdata.fda.gov
July 28, 2017K163352WheelchairIORSubstantially EquivalentKunshan Hi-Fortune Health Products Co., Ltd.accessdata.fda.gov
February 29, 2012K112815QUANTUM BARIATRIC 451ITISubstantially EquivalentPride Mobility Product Corporrationaccessdata.fda.gov
October 23, 2009K092961JAZZY FRONTIEITISubstantially EquivalentPride Mobility Products Corp.accessdata.fda.gov
August 17, 2007K072165VICTORY THREE WHEEL SCOOTER, MODEL: SC610INISubstantially EquivalentPride Mobility Products Corp.accessdata.fda.gov
August 1, 2007K071949VICTORY, 4 WHEEL SCOOTER / MODEL, # SC1740INISubstantially EquivalentPride Mobility Products Corp.accessdata.fda.gov
October 6, 2004K042612JAZZY 600ITISubstantially EquivalentPride Mobility Products Corp.accessdata.fda.gov

Compare with other makers

Updated March 26, 2025. 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.