BEUDAMED
    Product Code: ILM FDA class 2 21 CFR 890.5100

    Bath, Sitz, Powered

    Physical Medicine

    A Powered Sitz Bath is an electrically heated therapeutic bathing device used in Physical Medicine to immerse the perineal and gluteal region in warm water, used to promote healing, reduce inflammation, and relieve discomfort following perineal surgery, hemorrhoidectomy, or childbirth. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is ILM, regulated under 21 CFR 890.5100, within the Physical Medicine medical specialty.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    13

    Research product code ILM in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    ILM
    Device Class
    FDA class 2
    Regulation Number
    890.5100
    Medical Specialty
    Physical Medicine
    Review Panel
    PM
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K953796 BANKS HYDRO-THERAPY CHAIR
    K823327 PORTABLE SHOWER BATH