BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IsoFlex LAL

    Reg #: 1831750 · FEI: 1831750 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    STRYKER MEDICAL
    Registration Number
    1831750
    FEI Number
    1831750
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3800 E. CENTRE AVE.
    City
    Portage
    State
    MI
    ZIP
    49002
    Country
    US

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    Products

    Device Name Product Code
    Mattress, Flotation Therapy, Non-Powered IKY

    Proprietary Names

    IsoFlex LAL Pioneer Stretcher Mattress Ultra Comfort Mattress ProForm Enhanced Comfort Mattress IsoFlex SE ComfortGel SE Ultra ComfortSE IsoTour , mattress extender (accessory), turn assist upgrade kit (accessory) Non-Powered Bariatric Support Surface ComfortGel

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility