BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Otto Bock Manufacturing Konigsee GmbH

    Reg #: 9681725 · FEI: 1000413464 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    4
    Classifications
    3

    Registration Details

    Registration Name
    Otto Bock Manufacturing Konigsee GmbH
    Registration Number
    9681725
    FEI Number
    1000413464
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    LINDENSTRASSE 13
    City
    Koenigsee Thuringia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K060936

    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
    Accessories, Wheelchair KNO
    Components, Wheelchair KNN
    Wheelchair, Standup IPL

    Proprietary Names

    Various models Paragolfer

    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) Complaint File Establishment per 21 CFR 820.198