BEUDAMED
    FDA Registration Active 🇨🇳 China

    Kunshan Hi-Fortune Health Products Co., Ltd.

    Reg #: 3009265647 · FEI: 3009265647 · Expires 2026
    View on FDA
    Products
    32
    Proprietary Names
    44
    Establishment Types
    2
    Classifications
    32

    Registration Details

    Registration Name
    Kunshan Hi-Fortune Health Products Co., Ltd.
    Registration Number
    3009265647
    FEI Number
    3009265647
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    NO.625 Juxiang Road, Zhangpu Town
    City
    Kunshan City, Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K112815

    Owner / Operator

    Firm Name
    Kunshan Hi-Fortune Health Products Co., Ltd.
    Operator Number
    10036888
    Address
    NO.625 Juxiang Road, Zhangpu Town
    City
    Kunshan City
    State
    Jiangsu
    Postal Code
    215321
    Country
    CN
    Correspondent
    hongfa zhi

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Wheelchair, Powered ITI
    Bed, Therapeutic, Ac-Powered, Adjustable Home-Use LLI
    Splint, Hand, And Components ILH
    Components, Exercise IOD
    Powered Stairway Chair Lift PCD
    Cushion, Wheelchair IMP
    Belt, Wheelchair IQB
    Vehicle, Motorized 3-Wheeled INI
    Board, Scooter, Prone KNL
    Device, Patient Transfer, Powered FRZ
    Footrest, Wheelchair IMM
    Restraint, Wheelchair, Non-Protective KID
    Hill Holder, Wheelchair INA
    Chair, With Casters INM
    Holder, Crutch And Cane, Wheelchair IMZ
    Accessories, Wheelchair KNO
    Brake, Extension, Wheelchair IMW
    Support, Head And Trunk, Wheelchair IMS
    Lift, Patient, Non-Ac-Powered FSA
    Handrim, Wheelchair IMO
    Walker, Mechanical ITJ
    Chair, Adjustable, Mechanical INN
    Wheelchair, Mechanical IOR
    Lift, Patient, Ac-Powered FNG
    Cuff, Pusher, Wheelchair INC
    Climber, Curb, Wheelchair IMN
    Armrest, Wheelchair IML
    Device, Anti-Tip, Wheelchair IMR
    Board, Lap, Wheelchair IMX
    Components, Wheelchair KNN
    Attachment, Commode, Wheelchair INB
    Armboard, Wheelchair IMY

    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 REVO S67 BAJA BANDIT patient lift--HY108 adn HY101-01A HY201 HY601 HY603 WHILL Model C2 Manual wheelchair accessary(Footrest) PrideMobility HP358EA Electrically Powered Wheelchair Scooter Model R Electrically Powered Wheelchair (HP206) Electrically powered wheelchair (HP202) MEDICAL DEPOT d/b/a Drive DeVilbiss Healthcare REVO S66 GoGo Super Portable Ceiling hoist-CH100 NIP ROLLATOR Electrically Powered Wheelchair -Model HP358E 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 JAZZY EITE HD JZ EVO 613 HP458E Electrically Powered Wheelchair Electrically Powered Wheelchair P15 toilet lift-LT100 commode chair

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)