510(k) Report

Devices descending from K233926

4 later devices reach accufit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251594truFlexSyrma Johari Medtech Limited20250—
+1K241685SofWave SystemSofwave Medical, Ltd.20242—
+2K250146SofWave SystemSofwave Medical, Ltd.20251—
+3K251746Pure ImpactSofwave Medical, Ltd.20250—