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510(k) Data Aggregation

    K Number
    K232677
    Device Name
    Reia pessary
    Manufacturer
    Reia, LLC
    Date Cleared
    2024-05-21

    (263 days)

    Product Code
    HHW
    Regulation Number
    884.3575
    Why did this record match?
    Applicant Name (Manufacturer) :

    Reia, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reia pessary is indicated for the temporary, non-surgical management of Pelvic Organ Prolapse.
    Device Description
    The Reia pessary is a collapsible vaginal pessary for non-surgical treatment of pelvic organ prolapse. The Reia pessary is reusable by a single user and is intended for prescription home use following an in-office size fitting process performed by a healthcare professional using fitting pessaries. The Reia pessary is placed in the vagina, similar to a tampon or diaphragm, and by supporting the vaginal wall, the pessary prevents the descending organs from dropping into the vaginal canal. Similar to currently available pessaries, the Reia pessary has been evaluated for continuous use; however, its collapsible design enables simpler insertion and removal. The Reia pessary is made entirely of medical-grade silicone and is a single part. The geometry of the pessary and the flexible nature of the silicone allows the Reia pessary to collapse to facilitate easy, comfortable insertion and removal. In its supportive state, the Reia pessary is domed at the top with a stem at the bottom. The end of the stem has a large loop that allows the user to easily locate, grasp, and pull the pessary out for removal. The expandable and collapsible technology fits the user's anatomy during insertion, use, and removal. The Reia pessary is designed for self-management and to be easily collapsed for insertion and removal by any user. To insert the pessary, a user (e.g., patient or practitioner) pinches the outside of the pessary to elongate it into a narrower shape, allowing for easier, more comfortable insertion. Once it is released in the vagina, the pessary naturally expands to return to its supportive state. To remove the user pulls on the loop to re-elongate the pessary allowing for easier, more comfortable removal. The Reia pessary is manually cleaned with soap and water by the user in the home environment or a healthcare facility between periods of use. The Reia fitting pessaries are manually cleaned and sterilized at a healthcare facility between uses.
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