BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Extreme X8

    Reg #: 3003650116 · FEI: 3003650116 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MAGIC MOBILITY
    Registration Number
    3003650116
    FEI Number
    3003650116
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3 International Court
    City
    Scorsby Victoria
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K211574

    Owner / Operator

    Firm Name
    Magic Mobility
    Operator Number
    9034065
    Address
    3 International Court, --
    City
    SCORESBY
    State
    Victoria
    Postal Code
    3179
    Country
    AU
    Correspondent
    Terence - Walsh

    US Agent

    Business Name
    Sunrise Medical
    Contact Name
    Tanisha Gregory
    Address
    12002 Volunteer Parkway
    City
    Mount Juliet
    State
    TN
    ZIP
    37122
    Country
    US
    Email
    [email protected]
    Phone
    800 3334000

    Products

    Device Name Product Code
    Wheelchair, Powered ITI

    Proprietary Names

    Extreme X8

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device