FDA 510(k) Applications for Medical Device Product Code "NGX"
(Stimulator, Muscle, Powered, For Muscle Conditioning)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K182440 | A-1 Engineering | Body System | 02/26/2019 |
| K143207 | Actegy, Ltd | Revitive IX (OTC) | 03/23/2015 |
| K210825 | Actegy, Ltd. | Revitive Medic Coach (Model Number 5575AQ) | 12/17/2021 |
| K190924 | Actegy, Ltd. | Revitive Medic Plus, Revitive Advanced 2 | 07/05/2019 |
| K192887 | Actegy, Ltd. | Revitive Medic Plus, Revitive Advanced 2 | 05/04/2020 |
| K152480 | Actegy, Ltd. | Revitive Medic; Revitive MV; Revitive LV | 03/31/2016 |
| K141919 | AD REM TECHNOLOGY SARL | VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR | 06/16/2015 |
| K151722 | AIME MEDICAL INC | Slim UP ULTRA | 03/18/2016 |
| K152420 | AK BEAUTY ENTERPRISES, LLC | AK Body Toning Device | 12/01/2016 |
| K093999 | ARP MANUFACTURING, INC | ARP POV SPORT | 08/10/2010 |
| K201257 | Arrive Systems Inc | MI.BO. « MyoBoost EMS System (MB-1000, MB-600, MB-400) | 04/06/2021 |
| K220938 | Aura Wellness, LLC | Nova HD+ | 08/22/2023 |
| K231318 | Beijing ADSS Development Co., Ltd. | Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) | 07/07/2023 |
| K230024 | Beijing Sano Laser S&T Development Co., Ltd | HI-EMT MAGSHAPE | 09/06/2023 |
| K231368 | Bemer INT AG | Bemer Therapy System Evo | 06/09/2023 |
| K151834 | BEMER Int. AG | BEMER Classic Set, BEMER Pro-Set | 02/22/2017 |
| K210174 | Bemer INT. AG | BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set | 02/04/2021 |
| K071666 | BIO-MEDICAL RESEARCH CORP. | SLENDERTONE ENERVIVE, MODEL 561 | 03/12/2008 |
| K070142 | BIO-MEDICAL RESEARCH CORP. | SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20 | 03/23/2007 |
| K180688 | Bio-Medical Research Ltd | SLENDERTONE CoreFit Abs 8, Type 734 | 10/25/2018 |
| K203513 | Bio-Medical Research Ltd | SLENDERTONE Evolve Abs, Type 735 | 02/10/2021 |
| K151903 | BIO-MEDICAL RESEARCH LTD. | Slendertone connect Abs | 11/06/2015 |
| K161974 | Bio-Medical Research Ltd. | SLENDERTONE« Connect Abs, Type 570 | 11/01/2016 |
| K030708 | BIO-MEDICAL RESEARCH, LTD. | SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515 | 06/25/2003 |
| K022855 | BIO-MEDICAL RESEARCH, LTD. | SLENDERTONE FLEX BOTTOM & THIGH TONING SYSTEM, TYPE 511 | 03/06/2003 |
| K100556 | BIO-MEDICAL RESEARCH, LTD. | SLENDERTONE FLEX MAX, MODEL 517 US | 08/02/2010 |
| K010335 | BIO-MEDICAL RESEARCH, LTD. | SLENDERTONE FLEX, MODEL, 512 | 09/27/2001 |
| K052969 | BIO-MEDICAL RESEARCH, LTD. | SLENDERTONE GYMBODY, MODEL 512-01 | 11/16/2005 |
| K100320 | BIO-MEDICAL RESEARCH, LTD. | SLENDERTONE SYSTEM ULTRA MODEL E70/X70 | 05/05/2010 |
| K072553 | BIO-MEDICAL RESEARCH, LTD. | SYSTEM-ARMS, MODEL 390,E60 | 12/14/2007 |
| K083164 | BIO-MEDICAL RESEARCH, LTD. | SYSTEM-ARMS, MODELS 390, X60 | 12/16/2008 |
| K072294 | BIO-MEDICAL RESEARCH, LTD. | SYSTEM-MINI, MODELS: 390, E30 | 10/25/2007 |
| K201239 | Bios s.r.l. | NuEra Tight Family, EMS Model | 12/31/2020 |
| K200382 | BTL | BTL-703-2 | 01/06/2021 |
| K163165 | BTL INDUSTRIES, INC | AM-100 | 02/16/2017 |
| K180813 | BTL Industries, Inc. | BTL 799-2 | 06/14/2018 |
| K190456 | BTL Industries, Inc. | BTL 799-2L | 07/05/2019 |
| K182106 | BTL Industries, Inc. | BTL 799-2T | 10/23/2018 |
| K181419 | Casgarum Investment, S.L. | FLIX-EMS | 05/14/2019 |
| K083140 | CHATTANOOGA GROUP | COMPEX SPORT PLUS | 02/09/2009 |
| K011880 | COMPEX S.A. | COMPEX SPORT | 04/17/2002 |
| K111476 | CONTOUR TECHNOLOGY | CONTOUR TECHNOLOGY MUSCLE STIMULATOR | 05/23/2012 |
| K230261 | Creative Fitness Developments S.L. | Gnesis EMS Plus | 06/06/2023 |
| K170918 | DJO, LLC | Compex Sport Elite | 06/20/2017 |
| K201653 | DJO, LLC | Compex Sport Elite 3.0 | 11/27/2020 |
| K170903 | DJO, LLC | Compex Wireless USA | 06/19/2017 |
| K143551 | DJO, LLC | Compex Wireless USA | 04/28/2015 |
| K160323 | DK ELECTRONICS, LLC | FlowKeepers | 04/06/2017 |
| K061632 | DOMINO S.R.L. | GLOBUS PREMIUM MUSCLE STIMULATOR | 04/30/2007 |
| K183103 | Dongguan Yingfeng Metal & Plastic Products Co., Ltd | EMS Belt (Model MC0485) | 09/18/2019 |
| K081998 | ELECTRONIC WAVEFORM LABORATORY, INC. | H-WAVE SPORT | 07/09/2009 |
| K162744 | EVERYWAY MEDICAL INSTRUMENT CO., LTD. | Everyway OTC EMS, Model EV-805 | 08/03/2017 |
| K130723 | FAMIDOC TECHNOLOGY CO., LTD | FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL | 02/07/2014 |
| K192161 | Fast Fit LLC | FastFit EMS System | 01/22/2020 |
| K134001 | FIRSTKIND LIMITED | FIREFLY | 05/15/2014 |
| K201131 | Firstkind Limited | firefly T-2 | 05/28/2020 |
| K133225 | FIT-PRO KFT LTD. | E-FIT EF-1280 EMS MACHINE | 10/24/2014 |
| K202148 | Fit-Pro Ltd. | E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) | 08/25/2021 |
| K091833 | GEMORE TECHNOLOGY CO., LTD. | GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE. | 10/16/2009 |
| K102933 | GEMORE TECHNOLOGY CO., LTD. | GEM-TONE BODY TRAINING SYSTEM | 09/02/2011 |
| K102926 | GEMORE TECHNOLOGY CO., LTD. | GEMORE MUSCLE CONDITIONER; | 08/25/2011 |
| K093368 | GLOBAL MARKETING PARTNERS DBA GYMMAX USA | BUTTERFLY TONER MODEL GYM070 | 01/27/2010 |
| K182020 | Guangzhou Longest Science & Technology Co., Ltd. | Portable Electro-Stimulation Therapy Device | 09/17/2020 |
| K201845 | Guangzhou Longest Science & Technology Co., LTD. | Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) | 10/08/2020 |
| K202638 | Guangzhou Xinbo Electronic Co., Ltd. | Pain Therapy Device | 07/15/2021 |
| K212948 | Guangzhou Xinbo Electronic Co., Ltd. | Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I) | 11/01/2021 |
| K191938 | Heat In A Click LLC. | FitRelief TENS&EMS Wireless Device | 08/28/2020 |
| K192264 | Hivox Biotek Inc. | HIVOX Spopad EMS SP-911, SP-921 | 11/08/2019 |
| K143737 | HIVOX BIOTEK, INC. | EM25 - glute toning device | 07/27/2015 |
| K141921 | HIVOX BIOTEK, INC. | HIVOX SPOPAD EMS | 01/16/2015 |
| K180279 | Home Skinovations Ltd. | Silk'n MODEL H5003 device | 05/09/2018 |
| K133108 | HONG QIANG XING (SHENZHEN) ELECTRONICS LIMITED | FIT BELT | 08/05/2014 |
| K121719 | HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED | SM TENS & PMS | 05/10/2013 |
| K201354 | Hong Qiangxing (Shen Zhen) Electronics Limited | TENS & PMS | 12/11/2020 |
| K212413 | I-Motion Group Global Iberica S.L. | I-Motion | 05/26/2022 |
| K171092 | International Trade Group, Inc. | XiniWave II Model ECS322P | 07/10/2017 |
| K132179 | ION GENIUS INC | ARASYS | 04/28/2014 |
| K123158 | ION GENIUS INC | ION MAGNUM GENIUS | 06/21/2013 |
| K192039 | Johari Digital Healthcare Limited | Torc Body | 03/29/2020 |
| K212866 | Johari Digital Healthcare Limited | truSculpt flex | 12/03/2022 |
| K062439 | JOHARI DIGITAL HEALTHCARE, LTD. | POWERTONE, MODEL PT-11 | 01/08/2007 |
| K131291 | JOHARI DIGITAL HEALTHCARE, LTD. | TORC BODY | 06/14/2013 |
| K171035 | Katalyst Inc. | Katalyst Mark 1 Muscle Stimulation System | 09/06/2017 |
| K181199 | Katalyst Inc. | Katalyst Mark 1 Muscle Stimulation System Model 2 | 09/20/2018 |
| K190966 | Katalyst Inc. | Katalyst Training System | 02/03/2020 |
| K122414 | LETO ENTERPRISES INCORPORATION | AB COMMAND DUAL CHANNEL FITNESS BELT | 12/21/2012 |
| K102295 | LETO ENTERPRISES INCORPORATION | X2ABS DUAL CHANNEL FITNESS BELT | 02/18/2011 |
| K213748 | Lutronic Corporation | CoreLevee | 10/14/2022 |
| K211298 | Medical Cables S.L. | WiEMSpro | 08/25/2022 |
| K181955 | Medical Cables, S.L. | WiEMSpro | 02/12/2019 |
| K182794 | Medical Currents Ltd | BionicGym Powered Muscle Stimulator | 07/18/2019 |
| K122393 | MIGA MEDICAL CO., LTD. | TG-BODY MI&BODY S-TRAINER | 12/10/2013 |
| K182519 | Miha Bodytec Gmbh | Miha Bodytec II | 06/07/2019 |
| K201975 | Miha Bodytec Gmbh | miha bodytec II | 03/11/2021 |
| K221498 | Miha Bodytec GmbH | Miha Bodytec II | 10/07/2022 |
| K110057 | MJ SPECIALTY RETAIL | MINI MASSEUSE | 10/28/2011 |
| K222875 | Nanjing Vishee Medical Technology Co., Ltd. | Powered Muscle Stimulator (Model name:MagGraver F200) | 03/09/2023 |
| K223797 | Neuro20 Technologies | Neuro20 Pro System | 02/23/2023 |
| K191181 | NeuX Technologies, Inc. | NXPRO Neuromuscular Electrical Stimulation Device | 10/11/2019 |
| K200545 | Pollogen, Ltd | Legend Pro DMA | 10/21/2021 |
| K133965 | SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. | OTC EMS STIMULATOR | 06/16/2014 |
| K231136 | Shenzhen KeLuTongDa Industrial Co.,Ltd. | Fitness Belt (Model: KLT-07) | 06/16/2023 |
| K181728 | Shenzhen Kentro Medical Electronics Co., Ltd | Muscle Trainer | 10/17/2018 |
| K211942 | Shenzhen OSTO Technology Company Limited | Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) | 12/13/2021 |
| K172876 | Smartmissimo Technologies Pte Ltd | PowerDot PD-01M | 12/04/2017 |
| K150078 | Smartmissimo Technologies Pte Ltd | PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application) | 09/30/2015 |
| K091865 | SPORT-ELEC | SPORT-ELEC BODY CONTROL SYSTEM | 11/13/2009 |
| K092142 | SPORT-ELEC | SPORT-ELEC BODY CONTROL SYSTEM BS | 02/05/2010 |
| K092476 | SPORT-ELEC | SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4M | 05/07/2010 |
| K081026 | SPORT-ELEC S.A. | BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5 | 11/05/2008 |
| K061914 | SPORT-ELEC S.A. | SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS | 07/26/2007 |
| K020427 | THE DEZAC GROUP | AB BELT | 09/13/2002 |
| K020429 | THE DEZAC GROUP | AB BELT PRO | 09/13/2002 |
| K143059 | TONE-A-MATIC INTERNATIONAL INC. | TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator) | 01/26/2015 |
| K183454 | Tyece Ltd. | Tyece OTC EMS System | 02/26/2019 |
| K172241 | Tyece Ltd. | Tyece OTC EMS System, Model EM35 | 11/20/2017 |
| K031611 | VALMED CORP. | P4-FITNESS | 09/29/2004 |
| K222386 | VB Technologies AG | Visionbody | 02/24/2023 |
| K202653 | Well Brain International Ltd. | Gymform Total ABS | 01/15/2021 |
| K142055 | WELL BRAIN INTERNATIONAL, LTD. | GYMFORM ABS & CORE | 05/11/2015 |
| K130074 | WELL BRAIN INTERNATIONAL, LTD. | GYMFORM ABS-A-ROUND | 08/15/2013 |
| K111781 | WELL BRAIN INTERNATIONAL, LTD. | GYMFORM DUAL FLEX BELT MODEL WB-162 | 07/11/2012 |
| K123075 | WELL-LIFE HEALTHCARE LIMITED | BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E | 07/11/2013 |
| K072168 | WELL-LIFE HEALTHCARE LIMITED | OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412 | 12/19/2007 |
| K102786 | WELL-LIFE HEALTHCARE LIMITED | WELL-LIFE OTC EMS SYSTEM | 07/01/2011 |
| K221200 | XBody Hungary Kft. | XBody Go USA, XBody Pro USA | 01/31/2023 |
| K190038 | XBody Hungary Kft. | Xbody Newave USA | 04/05/2019 |
| K220601 | Zimmer MedizinSysteme GmbH | CoolTone | 04/01/2022 |
| K192940 | Zimmer MedizinSysteme GmbH | CoolTone | 11/15/2019 |
| K182963 | Zimmer MedizinSysteme GmbH | emFieldPro | 06/21/2019 |
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