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510(k) Data Aggregation

    K Number
    K241748
    Device Name
    Intimate Rose Vaginal Dilators
    Manufacturer
    Plus EV Holdings dba Intimate Rose
    Date Cleared
    2024-08-14

    (57 days)

    Product Code
    HDX
    Regulation Number
    884.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Plus EV Holdings dba Intimate Rose

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intimate Rose Vaginal Dilators are tools intended for controlled dilation of the vagina. They can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex.
    Device Description
    The Intimate Rose Vaginal Dilators are intended to treat women suffering from vaginismus (including related dyspareunia). Vaginismus is the involuntary spasm of the muscles in the vaginal wall which then inhibits sexual intercourse by making it painful or impossible. Dyspareunia is the pain experienced during sexual intercourse caused by physical and/or emotional problems. The device is used as a tool to dilate the vagina in controlled stages. It is a reusable device that comes into contact with the vaginal mucosal membrane for a prolonged (> 24 hours to <= 30 days) duration. The Intimate Rose Vaginal Dilators are comprised of 8 progressively larger and color-coded medical-grade silicone dilators.
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    K Number
    K231430
    Device Name
    Intimate Rose Vaginal Dilators
    Manufacturer
    Plus EV Holdings dba Intimate Rose
    Date Cleared
    2023-06-07

    (21 days)

    Product Code
    HDX
    Regulation Number
    884.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Plus EV Holdings dba Intimate Rose

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intimate Rose Vaginal Dilators are tools intended to dilate the vagina in controlled stages to help relieve symptoms of vaginismus.
    Device Description
    The Intimate Rose Vaginal Dilators are intended to treat women suffering from vaginismus (including related dyspareunia). Vaginismus is the involuntary spasm of the muscles in the vaginal wall which then inhibits sexual intercourse by making it painful or impossible. Dyspareunia is the pain experienced during sexual intercourse caused by physical and/or emotional problems. The device is used as a tool to dilate the vagina in controlled stages. It is a reusable device that comes into contact with the vaginal mucosal membrane for a prolonged (> 24 hours to ≤ 30 days) duration. The Intimate Rose Vaginal Dilators are comprised of 8 progressively larger and color-coded medical-grade silicone dilators.
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    K Number
    K193364
    Device Name
    Intimate Rose Kegel Exercise System
    Manufacturer
    Plus EV Holdings dba Intimate Rose
    Date Cleared
    2020-08-24

    (264 days)

    Product Code
    HIR
    Regulation Number
    884.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    Plus EV Holdings dba Intimate Rose

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intimate Rose Kegel Exercise System is indicated for the strengthening of the perineal pelvic floor muscles by providing resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, low tone in the pelvic floor, which can cause or contribute to health issues including urinary incontinence and sexual dysfunction.
    Device Description
    The Intimate Rose Kegel Exercise System is a pelvic floor exercise device for use in strengthening the pelvic floor musculature. It is a reusable, over-the-counter device that is comprised of 6 progressively heavier and color-coded silicone weights. An Intimate Rose Kegel Exercise System weight is inserted into the vagina and is held in place by contracting the pelvic floor muscles. The weight of the Intimate Rose Kegel Exercise System device provides resistance as it is lifted with each contraction of the pelvic floor muscles. When utilized correctly, the device will move upward and inward when the user contracts her pelvic floor muscles. The body's angle while exercising controls the level of resistance.
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