BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SEARS 5 FOOT ACRYLIC BATHTUB/WHIRLPOOL

    K Number: K791718 · Decision Oct 4, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    72
    Applicant Total
    1
    Review Days
    37

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SEARS 5 FOOT ACRYLIC BATHTUB/WHIRLPOOL
    K Number
    K791718
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5100
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Universal-Kundle Corp.
    Date Received
    August 28, 1979
    Decision Date
    October 4, 1979
    Product Code
    ILJ
    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
    ILJ Bath, Hydro-Massage

    Similar 510(k) Clearances

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

    PARKER 500

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    IMMERSION HYDROBATH

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MBATH 1000 (60)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SUPERIOR BATH, MODEL 6300

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CASCADE BATH, MODEL 6900

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all