BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    CoolTone

    Reg #: 8010720 · FEI: 7759 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ZIMMER MEDIZINSYSTEME GMBH
    Registration Number
    8010720
    FEI Number
    7759
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    JUNKERSSTRASSE 9
    City
    NEU-ULM Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K192940

    Owner / Operator

    Firm Name
    ZIMMER MEDIZINSYSTEME GMBH
    Operator Number
    8010720
    Address
    JUNKERSSTRASSE 9, --
    City
    NEU-ULM
    State
    DE-NOTA
    Postal Code
    89231
    Country
    DE

    US Agent

    Business Name
    ZIMMER MEDIZINSYSTEMS CORP.
    Contact Name
    Robert Wilber
    Address
    3 Goodyear, Suite B
    City
    IRVINE
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    800 3273576

    Products

    Device Name Product Code
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX

    Proprietary Names

    CoolTone

    Establishment Types

    Manufacture Medical Device