FDA 510(k)

Livi Device

K-Number: K252005 · 2026-03-20

Decision Date2026-03-20

Product CodeHEB

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Livi Device is a medical device manufactured by Liviwell, Inc.. It received FDA 510(k) clearance on 2026-03-20 under approval number K252005. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Livi Device?

Livi Device is a medical device that received FDA 510(k) clearance on 2026-03-20. It is manufactured by Liviwell, Inc.. The 510(k) number is K252005.

When was Livi Device approved by the FDA?

Livi Device received FDA 510(k) clearance on 2026-03-20, under approval number K252005.

What company makes Livi Device?

Livi Device is manufactured by Liviwell, Inc..

What is the FDA product code for Livi Device?

The FDA product code for Livi Device is HEB.

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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.