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510(k) Data Aggregation
K Number
K230997Device Name
EvoWalk 1.0 System
Manufacturer
Evolution Devices, Inc.
Date Cleared
2023-12-28
(265 days)
Product Code
GZI
Regulation Number
882.5810Why did this record match?
Applicant Name (Manufacturer) :
Evolution Devices, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EvoWalk 1.0 System is 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., stoke, damage to pathways to the spinal cord). The EvoWalk 1.0 System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the flexion or extension; thus, it also may improve the individual's gait.
Device 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 in adult individuals with muscle weakness related to upper motor neuron diseaselinjury (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.
The EvoWalk 1.0 system consists of the EvoWalk device with an elastic band and built-in rechargeable lithium polymer battery, and the accessories including the EvoWalk mobile application, micro USB type charge cable with charge port, lead cables (one single channel and one dual channel), eight sets of electrodes for each channel, instructions for use (IFU), and a carrying case.
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