510(k) Report

Devices descending from K113017

9 later devices reach Sys*Stim 240 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223802accufitMettler Electronics Corporation20235—
+1K213655HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)Hilltek, LLC20231—
+1K123177Stimlase 2000 Low Level Laser Therapy SystemLaserstim, Inc.20130—
+2K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali Nezakati20260—
+2K233926accufitMettler Electronics Corporation20244—
+3K251594truFlexSyrma Johari Medtech Limited20250—
+3K241685SofWave SystemSofwave Medical, Ltd.20242—
+4K250146SofWave SystemSofwave Medical, Ltd.20251—
+5K251746Pure ImpactSofwave Medical, Ltd.20250—