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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 the device name listed in this FDA 510(k) record. The listed applicant is Evolution Devices, Inc.. It received FDA 510(k) clearance on 2023-12-28 under 510(k) 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. The listed applicant is Evolution Devices, Inc.. The 510(k) number is K230997.

When did EvoWalk 1.0 System receive FDA 510(k) clearance?

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

Who is the listed applicant for EvoWalk 1.0 System?

The FDA 510(k) record lists Evolution Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EvoWalk 1.0 System?

The FDA product code for EvoWalk 1.0 System is GZI.

Related Devices (Code: GZI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

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

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