EvoWalk 1.0 System

FDA 510(k) K230997 · Evolution Devices, Inc.

Substantially Equivalent

510(k) numberK230997

Submission

Device name
EvoWalk 1.0 System
Applicant
Evolution Devices, Inc.
Oakland, CA, US
Received
April 7, 2023
Decision date
December 28, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GZI – Stimulator, Neuromuscular, External Functional
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5810
Specialty
Neurology

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Questions and answers

When was EvoWalk 1.0 System cleared by the FDA?

EvoWalk 1.0 System (K230997) received a 510(k) decision of Substantially Equivalent on December 28, 2023, 265 days after the submission was received.

What is the product code of K230997?

The FDA product code is GZI – Stimulator, Neuromuscular, External Functional, a Class II (moderate risk) device regulated under 21 CFR 882.5810.