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FDA 510(k)

Livi Device

K-Number: K252005 · 2026-03-20

ApplicantLiviwell, Inc.
Decision Date2026-03-20
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Livi Device is the device name listed in this FDA 510(k) record. The listed applicant is Liviwell, Inc.. It received FDA 510(k) clearance on 2026-03-20 under 510(k) 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. The listed applicant is Liviwell, Inc.. The 510(k) number is K252005.

When did Livi Device receive FDA 510(k) clearance?

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

Who is the listed applicant for Livi Device?

The FDA 510(k) record lists Liviwell, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Livi Device?

The FDA product code for Livi Device is HEB.

Related Devices (Code: HEB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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