FDA.reportPublic FDA data

EvoWalk

Primary DI
00860011699309
Brand
EvoWalk
Company
Evolution Devices, Inc.
Model
1.0
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 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.
Published
2025-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GZIStimulator, Neuromuscular, External Functional

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZIStimulator, Neuromuscular, External FunctionalNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230997000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230997000EvoWalk 1.0 SystemEvolution Devices, Inc.2023-12-28GZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011699309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011699309008600116993098600116993090860011699309

GMDN Terms#

Term, Definition table
TermDefinition
Gait-enhancement electrical stimulation system, externalAn assembly of devices that applies electrical stimuli to the lower extremity nerves (e.g., peroneal or femoral) or muscles (e.g., those that cause ankle dorsiflexion), to cause the muscles in the leg to contract, thus improving the gait in a patient suffering from partial paralysis of the lower extremities or other neuromuscular disorders. It typically includes electrodes and an external pulse generator (EPG), and may be incorporated into an external prosthesis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
116985408
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G345SL2000CIONICCionic, Inc.GZI2026-06-04
06970670070242XFTShenzhen XFT Medical LimitedGZI2026-04-14
06970670070259XFTShenzhen XFT Medical LimitedGZI2026-04-14
00852184003670Motor Point Probe, Synchrony Synapse Biomedical, Inc.GZI2025-10-31
00852184003694Electrode Cable, SingleSynapse Biomedical, Inc.GZI2025-10-31
00852184003700Electrode Cable, DualSynapse Biomedical, Inc.GZI2025-10-31
00852184003717Electrode Cable, TripleSynapse Biomedical, Inc.GZI2025-10-31
00852184003724Electrode Cable, Four Synapse Biomedical, Inc.GZI2025-10-31
00852184003762Electrode Cable KitSynapse Biomedical, Inc.GZI2025-10-31
00852184003786Sensor Boot SetSynapse Biomedical, Inc.GZI2025-10-31
00852184003793Sensor Boot - SmallSynapse Biomedical, Inc.GZI2025-10-31
00852184003809Sensor Boot - MediumSynapse Biomedical, Inc.GZI2025-10-31
00852184003816Sensor Boot - LargeSynapse Biomedical, Inc.GZI2025-10-31
00852184003649Clinical Kit, SynchronySynapse Biomedical, Inc.GZI2025-10-23
00852184003656Stimulator, SynchonySynapse Biomedical, Inc.GZI2025-10-23
00852184003663Sensor, SynchonySynapse Biomedical, Inc.GZI2025-10-23
00852184003687Patient Kit, SynchronySynapse Biomedical, Inc.GZI2025-10-23
00852184003779Kit, Wireless Charger USA 5WSynapse Biomedical, Inc.GZI2025-10-23
00810188050052L360 Thigh SystemBioness Medical, Inc.GZI2025-07-18
00810188050083L300 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050120L300 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050175L100 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050274L300 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050441H200 Wireless SystemBioness Medical, Inc.GZI2025-07-18
00810188050069L360 Thigh SystemBioness Medical, Inc.GZI2025-07-17
00810188050076L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050090L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050106L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050113L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050137L300 Go SystemBioness Medical, Inc.GZI2025-07-17