FDA 510(k)

Gnesis EMS Plus

Número K: K230261 · 2023-06-06

RequerenteCreative Fitness Developments S.L.

Data da decisão2023-06-06

Código do produtoNGX

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

What is the Gnesis EMS Plus?

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

When did Gnesis EMS Plus receive FDA 510(k) clearance?

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

Who is the listed applicant for Gnesis EMS Plus?

The FDA 510(k) record lists Creative Fitness Developments S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gnesis EMS Plus?

The FDA product code for Gnesis EMS Plus is NGX.

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Fonte oficial

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