BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Omnistim FX2 Portable

    Reg #: 3004929320 · FEI: 3004929320 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    TIC MEDIZINTECHNIK GMBH&CO.KG
    Registration Number
    3004929320
    FEI Number
    3004929320
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Endelner Feld 9
    City
    Dorsten North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K945508

    Owner / Operator

    Firm Name
    tic Medizintechnik GmbH&Co.KG
    Operator Number
    10024525
    Address
    Endelner Feld 9
    City
    Dorsten
    State
    North Rhine-Westphalia
    Postal Code
    46286
    Country
    DE
    Correspondent
    Christian Kleeberg

    US Agent

    Business Name
    Accelerated Care Plus
    Contact Name
    Lee Grasseschi
    Address
    1170 Trademark Dr Ste 104
    City
    Reno
    State
    NV
    ZIP
    89521
    Country
    US
    Email
    [email protected]
    Phone
    775 2231391

    Products

    Device Name Product Code
    Stimulator, Muscle, Powered IPF

    Proprietary Names

    Omnistim FX2 Portable Omnistim FX2 Cycle/Walk

    Establishment Types

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