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510(k) Data Aggregation

    K Number
    K221469
    Device Name
    PATI (Protector Against Tongue Injury)
    Manufacturer
    NeuroVice, LLC
    Date Cleared
    2023-02-22

    (278 days)

    Product Code
    JXL
    Regulation Number
    882.5070
    Why did this record match?
    Applicant Name (Manufacturer) :

    NeuroVice, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PATI device is a single-use (disposable) oral protector for use during spontaneous seizures and any circumstances requiring the protection of the teeth, lips, tongue, and buccal mucosa. The PATI is indicated for use with any individual aged 12 or older who suffers from seizures and can be used in a clinical or non-clinical environment.
    Device Description
    The Protector Against Tongue Injury (PATI) device is a symptom-management, oral device technology that helps to protect against oral injury during seizures, while also allowing fluids to naturally drain or be suctioned. The device will be administered by the patient, an assistant, or medical personnel, (such as hospital staff, EEG technicians, or first responders, including EMTs and paramedics), prior to full onset of a seizure. The device is single use and disposable.
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