FDA 510(k)

I-Motion

Número K: K212413 · 2022-05-26

RequerenteI-Motion Group Global Iberica S.L.

Data da decisão2022-05-26

Código do produtoNGX

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

I-Motion is the device name listed in this FDA 510(k) record. The listed applicant is I-Motion Group Global Iberica S.L.. It received FDA 510(k) clearance on 2022-05-26 under 510(k) number K212413. 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 I-Motion?

I-Motion is a medical device that received FDA 510(k) clearance on 2022-05-26. The listed applicant is I-Motion Group Global Iberica S.L.. The 510(k) number is K212413.

When did I-Motion receive FDA 510(k) clearance?

I-Motion received FDA 510(k) clearance on 2022-05-26, under 510(k) number K212413.

Who is the listed applicant for I-Motion?

The FDA 510(k) record lists I-Motion Group Global Iberica S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-Motion?

The FDA product code for I-Motion is NGX.

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