Class Class II

Break Wave (K252913)

K252913 2026-01-12 Traditional
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Description

Break Wave by Sonomotion, Inc., an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK252913
Clearance Date2026-01-12
Clearance TypeTraditional
Product CodeLNS
Regulation Number876.5990

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