FDA 510(k)

Break Wave

K号: K252913 · 2026-01-12

决定日期2026-01-12

产品代码LNS

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决定实质等同

器械摘要

Break Wave is the device name listed in this FDA 510(k) record. The listed applicant is Sonomotion, Inc.. It received FDA 510(k) clearance on 2026-01-12 under 510(k) number K252913. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Break Wave?

Break Wave is a medical device that received FDA 510(k) clearance on 2026-01-12. The listed applicant is Sonomotion, Inc.. The 510(k) number is K252913.

When did Break Wave receive FDA 510(k) clearance?

Break Wave received FDA 510(k) clearance on 2026-01-12, under 510(k) number K252913.

Who is the listed applicant for Break Wave?

FDA 510(k)记录中列出Sonomotion，Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Break Wave?

The FDA product code for Break Wave is LNS.

列明Sonomotion, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262200石清（BWSC-LP9-02）K261086Break Wave

官方来源

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