BEUDAMED
    Product Code: KTC FDA class 1 21 CFR 890.5125

    Bath, Sitz, Nonpowered

    Physical Medicine

    This device is a nonpowered sitz bath, a shallow basin designed to immerse the perineal and anal area in warm water, used in physical medicine and postoperative care to relieve pain and promote healing following perineal surgery, hemorrhoidectomy, or childbirth. It is classified as FDA Class 1, the lowest risk level, subject to general controls. The product code is KTC, regulated under 21 CFR 890.5125 within the Physical Medicine specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

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    510(k)s
    7
    FEI Numbers
    49
    Registration Numbers
    49
    Unique Applicants
    7
    Years Active
    11

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    Basic Information

    Product Code
    KTC
    Device Class
    FDA class 1
    Regulation Number
    890.5125
    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

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    Related 510(k) Clearances

    This FDA classification is associated with 7 510(k) clearances via K numbers.

    K Number Device Name
    K912179 THE SPRITZ BATH
    K890085 SIT-N-BATHE SITZ BATH
    K862600 SITZ BATH
    K851309 ABCO PLASTIC UTENSILS
    K841711 MAC LEE SITZ BATH
    K831762 SITZ BATH, SINGLE PATIENT USE #8100
    K800958 PERSONAL SITZ BATH KIT

    FEI Numbers

    This FDA classification entry is associated with 49 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 49 registration numbers. Click on an entry to view related FDA registrations.