BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ROHO® SOFFLEX® Mattress Overlay System

    Reg #: 3008630266 · FEI: 3008630266 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ROHO, Inc.
    Registration Number
    3008630266
    FEI Number
    3008630266
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1501 S 74th St
    City
    Belleville
    State
    IL
    ZIP
    62223
    Country
    US

    Owner / Operator

    Firm Name
    ROHO, INC.
    Operator Number
    1419507
    Address
    1501 S. 74th St., --
    City
    Belleville
    State
    IL
    Postal Code
    62223
    Country
    US

    Products

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

    Proprietary Names

    ROHO® SOFFLEX® Mattress Overlay System ROHO® DRY FLOATATION® Bariatric Kit ROHO® DRY FLOATATION® Mattress Overlay System ROHO® PRODIGY® Mattress Overlay System ROHO® SOFFLEX® 2 Mattress Overlay System ROHO® DRY FLOATATION® Isolette ROHO® DRY FLOATATION® Bariatric Mattress Overlay System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device