BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    TONE-A-MATIC INTERNATIONAL, INC.

    Reg #: 3006551156 · FEI: 3006551156 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    TONE-A-MATIC INTERNATIONAL, INC.
    Registration Number
    3006551156
    FEI Number
    3006551156
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    145 TRADERS BLVD, EAST,, UNIT 18
    City
    MISSISSAUGA Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K143059

    Owner / Operator

    Firm Name
    TONE-A-MATIC INTERNATIONAL, INC.
    Operator Number
    9102041
    Address
    145 TRADERS BLVD, EAST,, UNIT 18
    City
    MISSISSAUGA,
    State
    Ontario
    Postal Code
    L4Z-3L3
    Country
    CA
    Correspondent
    EMMANUEL C MBULU

    US Agent

    Business Name
    TAM INTERNATIONAL
    Contact Name
    ANNIA KORDIUK
    Address
    1051 CLINTON ST
    City
    Buffalo
    State
    NY
    ZIP
    14206
    Country
    US
    Email
    [email protected]
    Phone
    716 8520135

    Products

    Device Name Product Code
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
    Stimulator, Muscle, Powered IPF
    Electrode, Cutaneous GXY
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    Media, Electroconductive GYB

    Proprietary Names

    TAMTEC-HANA TENS / EMS (SPORT MUSCLE STIMULATOR) TAMTEC TDR 68-4 TAMTEC TDR 68-4 PRO TAMTEC8, TMT580 TONE-A-MATIC TAMTEC Multi-Functional Garment Electrodes Direct Connect Ab & Back Belt, Knee & Elbow Brace TONE-A-MATIC TDR68 TONE-A-MATIC TAMEXX Pad Prolonger Gel

    Establishment Types

    Manufacture Medical Device