OAKLAND, CA — Jan. 22, 2024 — Evolution Devices, Inc. is thrilled to announce that the EvoWalk 1.0 System has been granted FDA 510(k) clearance. The clearance allows commercial sale of the device in the United States. EvoWalk is a non-invasive, wearable functional electrical stimulation (FES) device intended to provide ankle dorsiflexion and/or assist knee flexion or extension in adults with foot drop or muscle weakness related to upper motor neuron diseases or injuries (e.g.; stroke, multiple sclerosis, damage to pathways in the spinal cord).

EvoWalk uses novel, patented algorithms to understand a person’s leg movements and electrically stimulate muscles in the affected leg, to help partially paralyzed patients walk. Improved walking should help these patients regain their independence. The EvoWalk device is controlled via an app that patients and clinicians use to set up the device. Clinicians can remotely track their patients’ progress to personalize their care plan.

Highlights of EvoWalk’s Innovative Approach:

• Innovative AI-Powered Wearable: With its advanced machine learning algorithms, EvoWalk adapts to each user's unique gait, offering a groundbreaking and personalized walking experience. 

• Sleek & Easy-to-use: Designed with direct user input, EvoWalk's compact, breathable build easily fits under clothing, minimizes sweating, and allows for simple one-handed use.

• One Device, Full Leg Support: The EvoWalk’s two stimulation channels offer comprehensive leg support, aiding both lower and upper leg muscles.

• Data-Driven Care: The EvoWalk mobile app enables patients to engage with their walking data and provides clinicians with actionable data to personalize care.

The clearance from the FDA marks a significant milestone in Evolution Devices’ journey to advance movement therapy with cutting-edge affordable technologies that enable anyone, anywhere to receive personalized rehabilitative care. The company’s goal is to improve the lives of individuals with mobility challenges. The FDA clearance signifies that EvoWalk meets FDA’s high standards of safety and effectiveness, validating the hard work and dedication of the team behind this life-changing technology. 

With FDA clearance achieved, Evolution Devices is now accelerating production to meet the growing demand for EvoWalk. The company will begin servicing the more than one thousand individuals who have expressed their interest by joining the EvoWalk interest list.

• For Patients: If you are an individual who could benefit from using EvoWalk, you can join the EvoWalk patient interest list below:

• For Clinicians: If you are a clinician or healthcare provider who would like to bring EvoWalk to their practice, you can join the EvoWalk clinician interest list below: