BEUDAMED
    FDA Registration Active 🇨🇳 China

    TME-UTA

    Reg #: 3014314933 · FEI: 3014314933 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    SHENZHEN ROUNDWHALE TECHNOLOGY CO. LTD.
    Registration Number
    3014314933
    FEI Number
    3014314933
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    202,2/F, Building 27, Dafa Industrial Park, Longxi Community, Longgang Street, Longgang District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K192087

    Owner / Operator

    Firm Name
    Shenzhen Roundwhale Technology Co. Ltd.
    Operator Number
    10057039
    Address
    202,2/F, Building 27, Dafa Industrial Park, Longxi Community, Longgang Street, Longgang District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518116
    Country
    CN
    Correspondent
    Kevin Zhang

    US Agent

    Business Name
    IRC USA
    Contact Name
    Charles Mack
    Address
    2950 E Lindrick Dr.
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

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

    Proprietary Names

    TME-UTA RHB2026GRY AE177 ZZACOMBOBDPT1 R-C3,R-C4A,R-C4B,R-C4C,R-C4D,CNT-TENS-100,Magic, M100A, M101A, R-C1-K01,M102A ZZACOMBO Combo Electrotherapy Device (M101A-UK1) ZZACOMBOBDPT2 R-C101J,

    Establishment Types

    Manufacture Medical Device