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510(k) Data Aggregation

    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
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K203288
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K203288

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    The Felix NeuroAI System is an external upper limb tremor stimulator cleared via a 510(k) pathway. The device's acceptance criteria are based on a superiority study (TRANQUIL study) against a sham control, demonstrating its effectiveness in aiding tremor-related functional limitations.

    1. Table of Acceptance Criteria and Reported Device Performance

    The core acceptance criterion for the Felix NeuroAI System was demonstrating superiority over sham stimulation in the primary effectiveness endpoint.

    Acceptance Criterion (Primary Endpoint)Reported Device Performance (Felix Group)
    Superiority of Felix versus Sham stimulation in Change in TETRAS modified Activities of Daily Living (mADL) score from baseline pre-stimulation to Day 90.Change in TETRAS mADL score (Felix vs. Sham):
    • Prespecified Primary Analysis (excluding missing data):
      • Felix: -6.9 ± 5.96 (mean ± SD)
      • Sham: -2.7 ± 4.12 (mean ± SD)
      • Difference of average paired difference: -4.2
      • 95% CI: [-6.2, -2.2]
      • p-value: **
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