FDA.reportPublic FDA data

EVOLUTION DEVICES, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30304188853030418885EVOLUTION DEVICES, INC.1N2026-01-011231 Stevenson Street STE 201 San Francisco CA US 94103

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3351581804377573K230997EvoWalk 1.0 SystemGZI2023-12-28

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GZI12023-12-28

PMN#

GUDID#

EvoWalk - 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.

Evolution Devices, Inc.

2025-08-06