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FDA 510(k)

EvoWalk 1.0 System

K-Number: K230997 · 2023-12-28

ApplicantEvolution Devices, Inc.
Decision Date2023-12-28
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EvoWalk 1.0 System is a medical device manufactured by Evolution Devices, Inc.. It received FDA 510(k) clearance on 2023-12-28 under approval number K230997. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EvoWalk 1.0 System?

EvoWalk 1.0 System is a medical device that received FDA 510(k) clearance on 2023-12-28. It is manufactured by Evolution Devices, Inc.. The 510(k) number is K230997.

When was EvoWalk 1.0 System approved by the FDA?

EvoWalk 1.0 System received FDA 510(k) clearance on 2023-12-28, under approval number K230997.

What company makes EvoWalk 1.0 System?

EvoWalk 1.0 System is manufactured by Evolution Devices, Inc..

What is the FDA product code for EvoWalk 1.0 System?

The FDA product code for EvoWalk 1.0 System is GZI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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