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FDA 510(k)

Break Wave

K-Number: K261086 · 2026-04-29

ApplicantSonomotion, Inc.
Decision Date2026-04-29
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Break Wave is a medical device manufactured by Sonomotion, Inc.. It received FDA 510(k) clearance on 2026-04-29 under approval number K261086. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Break Wave?

Break Wave is a medical device that received FDA 510(k) clearance on 2026-04-29. It is manufactured by Sonomotion, Inc.. The 510(k) number is K261086.

When was Break Wave approved by the FDA?

Break Wave received FDA 510(k) clearance on 2026-04-29, under approval number K261086.

What company makes Break Wave?

Break Wave is manufactured by Sonomotion, Inc..

What is the FDA product code for Break Wave?

The FDA product code for Break Wave is LNS.

Official Source

View on FDA Database →

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

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