BEUDAMED
    FDA Registration Active 🇺🇸 United States

    H-Wave OTC

    Reg #: 2023152 · FEI: 2023152 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ELECTRONIC WAVEFORM LAB, INC.
    Registration Number
    2023152
    FEI Number
    2023152
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5702 Bolsa Ave
    City
    Huntingtn Bch
    State
    CA
    ZIP
    92649
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160255

    Owner / Operator

    Firm Name
    ELECTRONIC WAVEFORM LABORATORY, INC.
    Operator Number
    2023152
    Address
    5702 Bolsa Ave, --
    City
    Huntington Beach
    State
    CA
    Postal Code
    92649
    Country
    US
    Correspondent
    W. J HEANEY

    Products

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

    Proprietary Names

    H-Wave OTC

    Establishment Types

    Manufacture Medical Device