BEUDAMED
    Product Code: LRL FDA unclassified

    Cushion, Hemorrhoid

    Unknown

    The Hemorrhoid Cushion is a device, typically an inflatable ring or pad, designed to relieve pressure on the anal region and provide comfort to patients suffering from hemorrhoids by redistributing seating pressure away from the affected area. This device is currently unclassified (Class U) by the FDA, meaning it has not been placed into a final regulatory classification category. The product code is LRL; no regulation number or medical specialty is on file for this entry. No special flags apply to this device.

    View on FDA
    510(k)s
    3
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    3
    Years Active
    20

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    Basic Information

    Product Code
    LRL
    Device Class
    FDA unclassified
    Medical Specialty
    Unknown
    Review Panel
    GU
    Submission Type
    7

    Device Characteristics

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

    Unclassified Reason

    1

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K072690 HEMAWAY SEAT
    K932396 PERI-COMFORT(TM) SEATING CUSHION
    K864470 HEMOREST(TM)

    FEI Numbers

    This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.