510(k) Report

Devices descending from K022855

53 later devices reach Slendertone Flex Bottom & Thigh Toning System, Type 511 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091865Sport-Elec Body Control SystemSport-Elec200923—
+1K070142Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts, Models 390, E20Bio-Medical Research Corp.200752—
+2K112934Neurotech RecoveryBio-Medical Research, Ltd.20120—
+2K092476Sport-Elec Body Control System, Model 4MSport-Elec201022—
+2K100320Slendertone System Ultra Model E70/X70Bio-Medical Research, Ltd.20104—
+2K092142Sport-Elec Body Control System BSSport-Elec201026—
+2K083105Kneehab XP Conductive Garment, Type 411Bio-Medical Research, Ltd.200914—
+2K072553System-Arms, Model 390,E60Bio-Medical Research, Ltd.200725—
+2K072294System-Mini, Models: 390, E30Bio-Medical Research, Ltd.20070—
+3K180688SLENDERTONE CoreFit Abs 8, Type 734Bio-Medical Research, Ltd.20181—
+3K182106BTL 799-2TBTL Industries, Inc.201812—
+3K180279Silk'n MODEL H5003 deviceHome Skinovations, Ltd.20180—
+3K151903Slendertone connect AbsBio-Medical Research, Ltd.20151—
+3K141921Hivox Spopad EmsHivox Biotek, Inc.20152—
+3K133108Fit BeltHong Qiangxing (Shenzhen) Electronics Limited20140—
+3K130074Gymform Abs-a-RoundWell Brain International, Ltd.20133—
+3K123075Buttock Muscle Stimulator Model WL-2413B; Buttock Muscle Stimulator Mode WL-2413EWell-Life Healthcare Limited20132—
+3K123642Muscle Stimulation SystemNiveus Medical, Inc.20131—
+3K110350Kneehab XPBio-Medical Research, Ltd.20119—
+3K092791Kneehab XP Controller, Model 411Bio-Medical Research, Ltd.20090—
+3K092793Modification to:Kneehab XP Conductive Garment, Model 411Bio-Medical Research, Ltd.20090—
+3K083164System-Arms, Models 390, X60Bio-Medical Research, Ltd.20080—
+4K203513SLENDERTONE Evolve Abs, Type 735Bio-Medical Research, Ltd.20210—
+4K202653Gymform Total ABSWell Brain International, Ltd.20210—
+4K192264HIVOX Spopad EMS SP-911, SP-921Hivox Biotek, Inc.20191—
+4K191587L360 Thigh SystemBioness, Inc.20190—
+4K190456BTL 799-2LBTL Industries, Inc.201911—
+4K161974SLENDERTONE® Connect Abs, Type 570Bio-Medical Research, Ltd.20160—
+4K151722Slim UP ULTRAAime Medical, Inc.20160—
+4K143737EM25 - glute toning deviceHivox Biotek, Inc.20150—
+4K150742Muscle Stimulation System 110Niveus Medical, Inc.20150—
+4K142055Gymform Abs & CoreWell Brain International, Ltd.20151—
+4K150413QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve StimulatorCymedica Orthopedics, Inc.20157—
+5K250038Muscle Stimulator Device (PZ-100)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+5K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd.20240—
+5K232181Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)Hebei JT Medical Co., Ltd.20241—
+5K230024HI-Emt MagshapeBeijing Sano Laser S&T Development Co.,Ltd20230—
+5K212832TimeWaver FrequencyTimewaver Production GmbH20211—
+5K200382BTL-703-2Btl20214—
+5K201239NuEra Tight Family, EMS ModelBios S.R.L.20200—
+5K181728Muscle TrainerShenzhen Kentro Medical Electronics Co., Ltd.20180—
+5K163067CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc.20164—
+6K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology Limited20260—
+6K253926DiacoreShenB Co., Ltd.20260—
+6K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+6K240234BTL-899MSBTL Industries, Inc.20242—
+6K232409Electromagnetic Stimulation SystemsShanghai Apolo Medical Technology Co., Ltd.20240—
+6K210674Shoulder PacemakerNcs Lab Srl20211—
+6K210604Intellihab SystemCymedica Orthopedics, Inc.20211—
+7K253408CoolToneZimmer Medizinsysteme GmbH20260—
+7K251594truFlexSyrma Johari Medtech Limited20250—
+7K220994Shoulder PacemakerTMNcs Lab Srl20220—
+7K220738Motive Knee WrapCymedica Orthopedics, Inc.20220—