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EvoWalk

FDA UDI

Class II (US FDA UDI)

by Evolution Devices, Inc.

Identity

Trade Name
EvoWalk FDA UDI
Generic Name
Gait-enhancement electrical stimulation system, external FDA UDI
Device Name
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. FDA UDI
Model / Reference
1.0 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00860011699309 FDA UDI
510(k) Number
K230997 FDA UDI
FDA Product Code
GZI FDA UDI
GMDN Term
Gait-enhancement electrical stimulation system, external FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5810 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Gait-enhancement electrical stimulation system, external

EvoWalk by Evolution Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gait-enhancement electrical stimulation system, external.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Evolution Devices, Inc.

Sources (1)

  • FDA UDI 0aa2c550-9d7c-4eba-b1d6-9f3fc73f8a19 34 fields · synced Jun 1, 2026