BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    AxonEnergy Integral

    Reg #: 9616494 · FEI: 3003117657 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH
    Registration Number
    9616494
    FEI Number
    3003117657
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Max-Naeder-Strasse 15
    City
    DUDERSTADT Lower Saxony
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K123795

    Owner / Operator

    Firm Name
    Ottobock SE & Co. KGaA
    Operator Number
    8010097
    Address
    Max-Naeder-Strasse 15
    City
    Duderstadt
    State
    Lower Saxony
    Postal Code
    37115
    Country
    DE

    US Agent

    Business Name
    Otto Bock HealthCare LP
    Contact Name
    Caleb Beck
    Address
    3820 West Great Lakes Drive
    City
    Salt Lake City
    State
    UT
    ZIP
    84120
    Country
    US
    Email
    [email protected]
    Phone
    801 9746647

    Products

    Device Name Product Code
    Hand, External Limb Component, Powered IQZ
    Electrode, Cutaneous GXY

    Proprietary Names

    AxonEnergy Integral AxonCharge Integral Tube Valve for Suction Socket Axon-Bus Prosthetic System AxonHook AxonSoft 2.2 Michelangelo Hand AxonRotation Axon-Bus Prosthetic System Service, Test AxonRotation Adapter AxonArm Ergo Suction Socket Electrode Michelangelo Hand Transcarpal AxonMaster Electrode

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device