FDA 510(k)

ViVi® Toga Premium

K-Number: K243522 · 2025-05-30

ApplicantThi Total Healthcare Innovation GmbH

Decision Date2025-05-30

Product CodeFYA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the ViVi® Toga Premium?

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

When was ViVi® Toga Premium approved by the FDA?

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

What company makes ViVi® Toga Premium?

ViVi® Toga Premium is manufactured by Thi Total Healthcare Innovation GmbH.

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

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

Other Devices by Thi Total Healthcare Innovation GmbH

K222214ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)

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Official Source

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