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EvoWalk
Evolution Devices, Inc. · Model 1.0 · UDI-DI 00860011699309
GZI
Prescription
1
510(k) clearances
50
Adverse events (1 deaths)
2
Recalls
41
Facilities
Description
The EvoWalk 1.0 system is a wearable non-invasive functional electrical stimulation (FES) device intended to provide ankle dorsiflexion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways in the spinal cord), thus providing treatment for foot drop. EvoWalk 1.0 can be used in a healthcare facility and home settings.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-07-19 | Myolyn Inc. | Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock. |
| 2008-08-06 | Innovative Neurotronics, Inc. | Knob responsible for regulating the amount of stimulation administered by the WalkAide System control unit may fall off while device is in use. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.