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FDA 510(k)

Gnesis EMS Plus

K-Number: K230261 · 2023-06-06

ApplicantCreative Fitness Developments S.L.
Decision Date2023-06-06
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Gnesis EMS Plus is a medical device manufactured by Creative Fitness Developments S.L.. It received FDA 510(k) clearance on 2023-06-06 under approval number K230261. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gnesis EMS Plus?

Gnesis EMS Plus is a medical device that received FDA 510(k) clearance on 2023-06-06. It is manufactured by Creative Fitness Developments S.L.. The 510(k) number is K230261.

When was Gnesis EMS Plus approved by the FDA?

Gnesis EMS Plus received FDA 510(k) clearance on 2023-06-06, under approval number K230261.

What company makes Gnesis EMS Plus?

Gnesis EMS Plus is manufactured by Creative Fitness Developments S.L..

What is the FDA product code for Gnesis EMS Plus?

The FDA product code for Gnesis EMS Plus is NGX.

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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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