BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MyCRO Band

    Reg #: 1721652 · FEI: 1721652 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    OTTO BOCK HEALTHCARE LP
    Registration Number
    1721652
    FEI Number
    1721652
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3820 West Great Lakes Drive
    City
    Salt Lake City
    State
    UT
    ZIP
    84120
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213587

    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

    Products

    Device Name Product Code
    Orthosis, Cranial, Laser Scan OAN
    Orthosis, Cranial MVA

    Proprietary Names

    MyCRO Band

    Establishment Types

    Manufacture Medical Device