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510(k) Data Aggregation

    K Number
    K122784
    Device Name
    NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT
    Manufacturer
    BIONESS, INC.
    Date Cleared
    2012-12-27

    (107 days)

    Product Code
    GZI
    Regulation Number
    882.5810
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K120853,K052329
    Why did this record match?
    Device Name :

    NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NESS L300 Foot Drop System is intended to provide ankle dorsiflexion in individuals (adults and pediatrics) who have foot drop following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot. The NESS L300 may improve gait, facilitate muscle re-education, prevent or retard disuse atrophy, maintain or increase joint range of motion, and increase local blood flow.

    Device Description

    The L300 Foot Drop System consists of Control Unit and Intelli-Sense Gait Sensor.

    AI/ML Overview

    I'm sorry, but this document does not contain the information requested regarding acceptance criteria and studies proving the device meets those criteria. The provided text is a 510(k) Summary and an FDA clearance letter for the Bioness L300 Foot Drop System, focusing on its substantial equivalence to predicate devices and expanded indications for use. It outlines the device description, indications for use, and regulatory information, but does not detail specific performance acceptance criteria or the results of a study designed to demonstrate them.

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