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510(k) Data Aggregation

    K Number
    K242214
    Device Name
    Sonu
    Manufacturer
    Sound Health Systems, Inc.
    Date Cleared
    2025-04-24

    (269 days)

    Product Code
    QZC
    Regulation Number
    874.6010
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sound Health Systems, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sonu is indicated for the relief of moderate to severe nasal congestion due to allergic and non-allergic rhinitis. Sonu is a treatment to be used at home by individuals 12 and older.
    Device Description
    Sonu is a non-invasive, over the counter (OTC) device designed for the relief of moderate to severe nasal congestion due to allergic and non-allergic rhinitis. Sonu uses acoustic resonance therapy to achieve its therapeutic effect. Sonu consists of an adjustable headband (Sonu Band) with integrated acoustic bone-conduction transducers (hardware), a USB-C Charging Cable (hardware), and a smartphone application (Sonu iOS App) (software) that connects to the Sonu Band. Sonu is indicated for individuals, aged 12 years old and above.
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    K Number
    DEN230045
    Device Name
    Sonu
    Manufacturer
    Sound Health Systems, Inc.
    Date Cleared
    2023-12-04

    (171 days)

    Product Code
    QZCQNT
    Regulation Number
    874.6010
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sound Health Systems, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sonu is indicated for the relief of moderate to severe nasal congestion due to allergic and non-allergic rhinitis. Sonu is a treatment to be used at home by individuals 22 and older.
    Device Description
    Sonu is a non-invasive, over-the-counter (OTC) device designed for the relief of moderate to severe nasal congestion due to allergic and non-allergic rhinitis at home. Sonu consists of an adjustable headband (Sonu Band) with integrated acoustic bone-conduction transducers, a USBC Charging Cable, and a smartphone application (Sonu iOS App) that connects to the Sonu Band.
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