BEUDAMED
    FDA Registration Active 🇺🇸 United States

    XT4

    Reg #: 3019677893 · FEI: 3019677893 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Sunrise Medical (US) LLC
    Registration Number
    3019677893
    FEI Number
    3019677893
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    12002 Volunteer Blvd
    City
    Mount Juliet
    State
    TN
    ZIP
    37122
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233877

    Owner / Operator

    Firm Name
    Sunrise Medical (US) LLC
    Operator Number
    9019832
    Address
    12002 Volunteer Blvd
    City
    Mount Juliet
    State
    TN
    Postal Code
    37122
    Country
    US
    Correspondent
    Tanisha Gregory

    Products

    Device Name Product Code
    Wheelchair, Standup IPL
    Wheelchair, Powered ITI

    Proprietary Names

    XT4 Magic XT4

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198