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Home News

Wearable FES Device Earns FDA Clearance

by The O&P EDGE
January 23, 2024
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Evolution Devices’ EvoWalk 1.0 System has been granted 510(k) clearance by the US Food and Drug Administration to allow commercial sale of the device in the United States.

EvoWalk is a non-invasive, wearable functional electrical stimulation (FES) device intended to provide ankle dorsiflexion and/or assist knee flexion or extension in adults with foot drop or muscle weakness related to upper motor neuron diseases or injuries (e.g., stroke, multiple sclerosis, or damage to pathways in the spinal cord).

The device uses novel, patented algorithms to understand a person’s leg movements and electrically stimulate muscles in the affected leg and is controlled via an app that patients and clinicians can use.

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