EvoWalk

GUDID 00860011699309

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.

Gait-enhancement electrical stimulation system, external

• Primary Device ID: 00860011699309
• NIH Device Record Key: 0aa2c550-9d7c-4eba-b1d6-9f3fc73f8a19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EvoWalk
• Version Model Number: 1.0
• Company DUNS: 116985408
• Company Name: Evolution Devices, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011699309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230997

FDA Product Code

• GZI: Stimulator, Neuromuscular, External Functional

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-14
• Device Publish Date: 2025-08-06