510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230997Substantially Equivalent

EvoWalk 1.0 System

Evolution Devices, Inc., Oakland CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230997 is the FDA 510(k) clearance record for EvoWalk 1.0 System, a class II device, cleared for Evolution Devices, Inc. on under FDA product code GZI (Stimulator, Neuromuscular, External Functional). FDA records list one 510(k) clearance for Evolution Devices, Inc. As of , FDA records show no recalls naming K230997.

Clearance record

Decision date
Received
(265 days to decision)
Product code
GZI Stimulator, Neuromuscular, External Functional
Regulation
21 CFR 882.5810
Device class
Class II
Review panel
Neurology
Applicant
Evolution Devices, Inc. 1111 Broadway Floor 3,, Oakland CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GZI

Trailing 12 months

FDA records hold no clearances under product code GZI in the trailing twelve months.

FDA records show no clearances under product code GZI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GZI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260