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510(k) Data Aggregation

    K Number
    K241897
    Device Name
    MOR
    Manufacturer
    Morari, Inc.
    Date Cleared
    2025-02-11

    (228 days)

    Product Code
    QRCORC
    Regulation Number
    876.5026
    Why did this record match?
    Applicant Name (Manufacturer) :

    Morari, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MOR System is indicated for the stimulation of healthy perineal muscles and nerves in adult males to improve or enhance sexual performance. It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.
    Device Description
    The MOR System is a drug-free wearable patch system with single-use electrode patches, a reusable pulse generator, and a smartphone app. Together, these components deliver user-defined electrical stimulation to the perineal region.
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