BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BANTEX BRAND WHEELCHAIRS

    K Number: K915262 · Decision Jan 13, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    445
    Applicant Total
    1
    Review Days
    55

    Basic Information

    Device Name
    BANTEX BRAND WHEELCHAIRS
    K Number
    K915262
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    BANTEX CORP.
    Date Received
    November 19, 1991
    Decision Date
    January 13, 1992
    Product Code
    IOR
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IOR Wheelchair, Mechanical

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IOR), ordered by most recent decision date.

    Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Bowhead ERA Wheelchairs

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Manual Wheelchair (MASY23)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Manual Wheelchair (SYIV100-CA9221)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Manual Wheelchair

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Merlexi Craft Bariatric series of manual wheelchairs

    FDA 510(k)
    FDA Class 1 ·Physical Medicine
    View all