BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Heartway S8 Power Mobility Scooter

    Reg #: 9616881 · FEI: 3002847480 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HEARTWAY MEDICAL PRODUCTS CO., LTD.
    Registration Number
    9616881
    FEI Number
    3002847480
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 6, Gongyequ 25th Rd., Baoshan Vil., Nantun Dist.,
    City
    TAICHUNG CITY
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K092155

    Owner / Operator

    Firm Name
    HEARTWAY MEDICAL PRODUCTS CO., LTD.
    Operator Number
    9030564
    Address
    No. 6, Gongyequ 25th Rd., Baoshan Vil., Nantun Dist.,
    City
    Taichung City
    State
    TW-TXG
    Postal Code
    408017
    Country
    TW

    US Agent

    Business Name
    ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY
    Contact Name
    SHU-CHEN CHENG
    Address
    2064 Tamarin Dr.
    City
    Columbus
    State
    OH
    ZIP
    43235
    Country
    US
    Email
    [email protected]
    Phone
    614 5888168

    Products

    Device Name Product Code
    Vehicle, Motorized 3-Wheeled INI

    Proprietary Names

    Heartway S8 Power Mobility Scooter

    Establishment Types

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