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510(k) Data Aggregation
K Number
K974514Device Name
EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR
Manufacturer
NEUROMOTION, INC.
Date Cleared
1998-02-06
(67 days)
Product Code
GZI
Regulation Number
882.5810Why 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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