510(k) Report

Devices descending from K231537

3 later devices reach SofWave System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233104SofWave SystemSofwave Medical, Ltd.20232—
+2K250146SofWave SystemSofwave Medical, Ltd.20251—
+3K251746Pure ImpactSofwave Medical, Ltd.20250—