510(k) Report

Devices descending from K230019

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230820SofWave SystemSofwave Medical, Ltd.20235—
+2K232455SofWave SystemSofwave Medical, Ltd.20234—
+3K240687SofWave SystemSofwave Medical, Ltd.20243—
+4K241685SofWave SystemSofwave Medical, Ltd.20242—
+5K250146SofWave SystemSofwave Medical, Ltd.20251—
+6K251746Pure ImpactSofwave Medical, Ltd.20250—