510(k) Report

Devices descending from K133225

19 later devices reach E-Fit EF-1280 Ems Machine through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202148E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)Fit-Pro, Ltd.20211—
+1K182519Miha Bodytec IIMiha Bodytec GmbH20193—
+1K181419Flix-EmsCasgarum Investment, S.L.20190—
+1K190038Xbody Newave USAXbody Hungary Kft.20194—
+1K181955WiEMSproMedical Cables S.L.20193—
+1K181199Katalyst Mark 1 Muscle Stimulation System Model 2Katalyst, Inc.20181—
+1K171035Katalyst Mark 1 Muscle Stimulation SystemKatalyst, Inc.20170—
+2K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+2K230261Gnesis EMS PlusCreative Fitness Developments S.L.20230—
+2K221200XBody Go USA, XBody Pro USAXbody Hungary Kft.20233—
+2K211298WiEMSproMedical Cables S.L.20220—
+2K212413I-MotionI-Motion Group Global Iberica S.L.20221—
+2K201975miha bodytec IIMiha Bodytec GmbH20212—
+2K192161FastFit EMS SystemFast Fit, LLC20200—
+3K242926XBody Go USA, XBody Pro USAXbody Hungary Kft.20250—
+3K250146SofWave SystemSofwave Medical, Ltd.20251—
+3K223797Neuro20 Pro SystemNeuro20 Technologies20230—
+3K221498Miha Bodytec IIMiha Bodytec GmbH20220—
+4K251746Pure ImpactSofwave Medical, Ltd.20250—