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510(k) Data Aggregation

    K Number
    K050991
    Device Name
    THE ODFS DROPPED FOOT STIMULATOR
    Manufacturer
    DEPARTMENT OF MEDICAL PHYSICS AND BIOMEDICAL ENG.
    Date Cleared
    2005-07-15

    (87 days)

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

    DEPARTMENT OF MEDICAL PHYSICS AND BIOMEDICAL ENG.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ODFS Dropped Foot Stimulator is intended to provide ankle dorsiflexion in individuals with dropped foot following an upper motor neuron injury. During the swing phase of gait, the ODFS electrically stimulates muscles in the leg and ankle of partially paralyzed individuals to provide flexion of the foot and may thus improve the individual's gait. Additional benefits of Functional Electrical Stimulation (FES) may include muscle re-education, prevention/retardation of disuse atrophy, maintained or increased joint range of motion, and increased local blood flow. The ODFS is a medical device and should only be used under medical supervision for adjunctive therapy for the treatment of dropped foot following an upper motor neuron injury.
    Device Description
    The ODFS Dropped Foot Stimulator (ODFSIII Version 6.2) is an external functional neuromuscular stimulator. The ODFS Dropped Foot Stimulator electrically stimulates the common peroneal nerve which may produce contraction of the appropriate muscles that cause dorsiflexion of the ankle in individuals who have lost the ability to do so following neurological injury. The device is comprised of a small belt-worn, single-channel, foot-switch controlled stimulator used with skin-surface stimulating electrodes. The surface electrodes are typically placed over the common peroneal nerve as it passes near the head of the fibula and the motor point of the tibialis anterior in the lower leg. The heel switch allows the delivery of stimulation to be triggered according to the gait of the user.
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