510(k) Report

Devices descending from K163165

23 later devices reach AM-100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232982EMS Sculpt MachineShandong Huamei Technology Co., Ltd.20240—
+1K180813BTL 799-2BTL Industries, Inc.201821—
+2K241601EMS (FlexPulse, MagnaCore, Magnetika)Cpmt Laser (Canadian Pioneer Medical Technology Corporation)20250—
+2K231318Electromagnetic Stimulator Device (Model EM Contouring and Tesla Duet)Beijing Adss Development Co., Ltd.20230—
+2K222875Powered Muscle Stimulator (Model name:MagGraver F200)Nanjing Vishee Medical Technology Co., Ltd.20230—
+2K213748CoreLeveeLutronic Corporation20220—
+2K182963emFieldProZimmer Medizinsysteme GmbH20193—
+2K182106BTL 799-2TBTL Industries, Inc.201812—
+3K192940CoolToneZimmer Medizinsysteme GmbH20192—
+3K190456BTL 799-2LBTL Industries, Inc.201911—
+4K250038Muscle Stimulator Device (PZ-100)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+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—
+4K220601CoolToneZimmer Medizinsysteme GmbH20221—
+4K200382BTL-703-2Btl20214—
+4K201239NuEra Tight Family, EMS ModelBios S.R.L.20200—
+5K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology Limited20260—
+5K253926DiacoreShenB Co., Ltd.20260—
+5K251378CoolToneZimmer Medizinsysteme GmbH20250—
+5K240234BTL-899MSBTL Industries, Inc.20242—
+5K232409Electromagnetic Stimulation SystemsShanghai Apolo Medical Technology Co., Ltd.20240—
+6K253408CoolToneZimmer Medizinsysteme GmbH20260—
+6K251594truFlexSyrma Johari Medtech Limited20250—