BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    AUVON, OTC TENS & EMS Unit, model TU2424

    Reg #: 3030379978 · FEI: 3030379978 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    FUSION ELECTRONIC TECHNOLOGY LIMITED
    Registration Number
    3030379978
    FEI Number
    3030379978
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    FLAT/RM A 12/F ZJ 300, 300 LOCKHART ROAD, WAN CHAI
    City
    Hongkong
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K243511

    Owner / Operator

    Firm Name
    Fusion Electronic Technology Limited
    Operator Number
    10089648
    Address
    FLAT/RM A 12/F ZJ 300, 300 LOCKHART ROAD, WAN CHAI
    City
    Hongkong
    State
    HK-NOTA
    Postal Code
    999077
    Country
    HK
    Correspondent
    Junyuan Chen

    Products

    Device Name Product Code
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH

    Proprietary Names

    AUVON, OTC TENS & EMS Unit, model TU2424 AUVON, OTC TENS & EMS Unit, model TA2224 AUVON, OTC TENS & EMS Unit, model TA3224

    Establishment Types

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