510(k) Report

Devices descending from K092142

26 later devices reach Sport-Elec Body Control System BS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123075Buttock Muscle Stimulator Model WL-2413B; Buttock Muscle Stimulator Mode WL-2413EWell-Life Healthcare Limited20132—
+1K092476Sport-Elec Body Control System, Model 4MSport-Elec201022—
+2K182106BTL 799-2TBTL Industries, Inc.201812—
+2K180279Silk'n MODEL H5003 deviceHome Skinovations, Ltd.20180—
+2K151722Slim UP ULTRAAime Medical, Inc.20160—
+2K143737EM25 - glute toning deviceHivox Biotek, Inc.20150—
+2K141921Hivox Spopad EmsHivox Biotek, Inc.20152—
+2K133108Fit BeltHong Qiangxing (Shenzhen) Electronics Limited20140—
+2K130074Gymform Abs-a-RoundWell Brain International, Ltd.20133—
+3K202653Gymform Total ABSWell Brain International, Ltd.20210—
+3K192264HIVOX Spopad EMS SP-911, SP-921Hivox Biotek, Inc.20191—
+3K190456BTL 799-2LBTL Industries, Inc.201911—
+3K142055Gymform Abs & CoreWell Brain International, Ltd.20151—
+4K250038Muscle Stimulator Device (PZ-100)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+4K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd.20240—
+4K232181Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)Hebei JT Medical Co., Ltd.20241—
+4K230024HI-Emt MagshapeBeijing Sano Laser S&T Development Co.,Ltd20230—
+4K200382BTL-703-2Btl20214—
+4K201239NuEra Tight Family, EMS ModelBios S.R.L.20200—
+4K181728Muscle TrainerShenzhen Kentro Medical Electronics Co., Ltd.20180—
+5K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology Limited20260—
+5K253926DiacoreShenB Co., Ltd.20260—
+5K240234BTL-899MSBTL Industries, Inc.20242—
+5K232409Electromagnetic Stimulation SystemsShanghai Apolo Medical Technology Co., Ltd.20240—
+6K253408CoolToneZimmer Medizinsysteme GmbH20260—
+6K251594truFlexSyrma Johari Medtech Limited20250—