510(k) Report

Devices descending from K190038

4 later devices reach Xbody Newave USA through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221200XBody Go USA, XBody Pro USAXbody Hungary Kft.20233—
+2K242926XBody Go USA, XBody Pro USAXbody Hungary Kft.20250—
+2K250146SofWave SystemSofwave Medical, Ltd.20251—
+3K251746Pure ImpactSofwave Medical, Ltd.20250—