# K230997: EvoWalk 1.0 System

- Pathway: 510(k) (Traditional)
- Applicant: Evolution Devices, Inc.
- Decided: Dec 28, 2023 after 265 days
- Product code: GZI (Stimulator, Neuromuscular, External Functional)
- Device class: 2
- Regulation: 21 CFR 882.5810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K800380 (1980). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173682: L300 Go System, Bioness, Inc. (2018) Summary page 5.

## Indications for 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., stroke, 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 foot and/or knee flexion or extension; thus, it also may improve the individual’s gait.

Source page: https://510kreport.com/device/K230997
Methodology: https://510kreport.com/methodology