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510(k) K230997

EvoWalk 1.0 System by Evolution Devices, Inc. — Product Code GZI

K230997 is an FDA 510(k) premarket notification submitted by Evolution Devices, Inc. for the device "EvoWalk 1.0 System". The FDA issued a decision of Substantially Equivalent on December 28, 2023. The device falls under product code GZI (Stimulator, Neuromuscular, External Functional), a Class II device regulated under 21 CFR 882.5810.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2023
Date Received
April 7, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Neuromuscular, External Functional
Device Class
Class II
Regulation Number
882.5810
Review Panel
NE
Submission Type

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  • K212149 — MyndMove 2.0 (March 3, 2022)
  • K213622 — Cionic Neural Sleeve NS-100 (February 14, 2022)
  • K202110 — MStim Drop Model: LGT-233 (November 5, 2021)
  • K193276 — Nerve and Muscle Stimulator (September 23, 2020)

FDA data resources