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510(k) Data Aggregation

    K Number
    K140886
    Device Name
    WALKAIDE SYSTEM
    Manufacturer
    INNOVATIVE NEUROTRONICS INC.
    Date Cleared
    2014-08-08

    (123 days)

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

    INNOVATIVE NEUROTRONICS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Innovative Neurotronics WalkAide External Neuromuscular Stimulator (WalkAide System) 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 System electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the gait in patients with chronic stroke. Medical benefits of Functional Electrical Stimulation (FES) may include prevention of disuse atrophy, increased local blood flow, muscle reeducation, 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. The WalkAide System consists of the WalkAide Patient Kit and the WalkAide Clinician Kit. The WalkAide Patient Kit comprises of all the components and accessories that the patient will take home and use. The Clinician System comprises the accessories that a clinician (i.e., orthotic specialist, physiotherapist, occupational therapist, etc.) will use to set up a patient's WalkAide.
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    K Number
    K123972
    Device Name
    WALKAIDE SYSTEM
    Manufacturer
    INNOVATIVE NEUROTRONICS INC.
    Date Cleared
    2013-04-01

    (96 days)

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

    INNOVATIVE NEUROTRONICS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Innovative Neurotronics WalkAide External Functional Neuromuscular Stimulator (WalkAide System) 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 System 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. The WalkAide System consists of the WalkAide Patient Kit and the WalkAide Clinician Kit . The WalkAide Patient Kit comprises of all the components and accessories that the patient will take home and use. The Clinician System comprises the accessories that a clinician (i.e., orthotic specialist, physiotherapist, occupational therapist, etc.) will use to set up a patient's WalkAide.
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    K Number
    K052329
    Device Name
    WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000
    Manufacturer
    INNOVATIVE NEUROTRONICS INC.
    Date Cleared
    2005-09-21

    (27 days)

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

    INNOVATIVE NEUROTRONICS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Innovative Neurotronics WalkAide System 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. The WalkAide System consists of the WalkAide Patient Kit and the WalkAide Clinician Kit . The WalkAide Patient Kit comprises of all the components and accessories that the patient will take home and use. The Clinician System comprises the accessories that a clinician (i.e., orthotic specialist, physiotherapist, occupational therapist, etc.) will use to set up a patient's WalkAide.
    Ask a Question

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