Cleared Traditional

EvoWalk 1.0 System

K230997 · Evolution Devices, Inc. · Neurology
Dec 2023
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K230997 is an FDA 510(k) clearance for the EvoWalk 1.0 System, a Stimulator, Neuromuscular, External Functional (Class II — Special Controls, product code GZI), submitted by Evolution Devices, Inc. (Oakland, US). The FDA issued a Cleared decision on December 28, 2023, 265 days after receiving the submission on April 7, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5810.

Submission Details

510(k) Number K230997 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2023
Decision Date December 28, 2023
Days to Decision 265 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZI — Stimulator, Neuromuscular, External Functional
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5810