FDA 510(k)

ViVi® Toga Premium

Número K: K243522 · 2025-05-30

RequerenteThi Total Healthcare Innovation GmbH

Data da decisão2025-05-30

Código do produtoFYA

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ViVi® Toga Premium is the device name listed in this FDA 510(k) record. The listed applicant is Thi Total Healthcare Innovation GmbH. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K243522. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ViVi® Toga Premium?

ViVi® Toga Premium is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Thi Total Healthcare Innovation GmbH. The 510(k) number is K243522.

When did ViVi® Toga Premium receive FDA 510(k) clearance?

ViVi® Toga Premium received FDA 510(k) clearance on 2025-05-30, under 510(k) number K243522.

Who is the listed applicant for ViVi® Toga Premium?

The FDA 510(k) record lists Thi Total Healthcare Innovation GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ViVi® Toga Premium?

The FDA product code for ViVi® Toga Premium is FYA.

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Fonte oficial

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