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    K Number
    K250096
    Device Name
    Felix NeuroAI System
    Manufacturer
    Fasikl Incorporated
    Date Cleared
    2025-07-01

    (168 days)

    Product Code
    QBC
    Regulation Number
    882.5897
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fasikl Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Felix™ NeuroAI™ Wristband is indicated to aid in tremor-related functional limitations in the upper limbs in adults with essential tremor.
    Device Description
    Fasikl's Felix™ NeuroAI™ Wristband is a wrist-worn, noninvasive, transcutaneous neurostimulation system. It is intended to be used by adult patients with essential tremor (ET) on a daily basis to aid in tremor-related functional limitations in the upper limbs. The system continuously monitors tremor frequency and tremor amplitude and automatically adjusts stimulation settings. The Felix system consists of the following components: Felix wristband (NeuroAI™ stimulator with integrated strap and detachable connector band), disposable electrode band, wireless charger, and smartphone application.
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