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510(k) Data Aggregation

    K Number
    K974514
    Device Name
    EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR
    Manufacturer
    NEUROMOTION, INC.
    Date Cleared
    1998-02-06

    (67 days)

    Product Code
    GZI
    Regulation Number
    882.5810
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEUROMOTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeuroMotion WalkAide is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of gait, the WalkAide electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the patient's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.
    Device Description
    The WalkAide is an external functional electrical stimulator. It is a small device that attaches to the leg just below the knee, near the head of the fibula. During a gait cycle, the WalkAide stimulates the common peroneal nerve, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle.
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