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510(k) Data Aggregation

    K Number
    K233435
    Device Name
    Peace N Quiet (0.7.0)
    Manufacturer
    PNQ Health
    Date Cleared
    2024-02-27

    (137 days)

    Product Code
    KLW
    Regulation Number
    874.3400
    Why did this record match?
    Applicant Name (Manufacturer) :

    PNQ Health

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Peace N Quiet device is indicated for use in the temporary relief of tinnitus symptoms. The device plays customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is for patients who are 18 years or older. This device should only be used with the advice of a physician, audiologist or other healthcare professional.
    Device Description
    The Peace N Quiet tinnitus device is software as a medical device implemented as a mobile application for patients suffering from tinnitus. The Peace N Quiet tinnitus mobile app can be downloaded from the Apple Store onto a personal Apple iPhone device facilitates a qualified healthcare professional (HCP). i.e., physician or audiologist, to provide professional counseling or education to the patient. The HCPs can direct and assist patients to self-administer customized treatments using the Peace N Quiet tinnitus device.
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