BEUDAMED
    FDA Registration Active 🇨🇳 China

    HIVOX OTC Electrical Stimulator, EM59-1

    Reg #: 3010355986 · FEI: 3010355986 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    HIVOX Electronics Co., Ltd.
    Registration Number
    3010355986
    FEI Number
    3010355986
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Building 1., No.10, DonGhuan Second Road, HuangJiang Town
    City
    Dong Guan City Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K203574

    Owner / Operator

    Firm Name
    HIVOX BIOTEK, INC.
    Operator Number
    9044329
    Address
    5 F., NO. 123, Xingde Road, Sanchong District
    City
    New Taipei City
    State
    TW-NOTA
    Postal Code
    24158
    Country
    TW

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

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

    Proprietary Names

    HIVOX OTC Electrical Stimulator, EM59-1 3-in-1 TENS/EMS device with heat HIVOX OTC Electrical Stimulator, EM59-2

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device