FDA Product Code
FDA Product Code NGX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5850
510(k) Clearances — 163 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K151834 | BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | 2017-02-22 | Traditional | PDF ↗ |
| K163165 | AM-100 | BTL Industries, Inc. | 2017-02-16 | Traditional | PDF ↗ |
| K152420 | AK Body Toning Device | Ak Beauty Enterprises, LLC | 2016-12-01 | Abbreviated | PDF ↗ |
| K161974 | SLENDERTONE® Connect Abs, Type 570 | Bio-Medical Research, Ltd. | 2016-11-01 | Special | PDF ↗ |
| K152480 | Revitive Medic; Revitive MV; Revitive LV | Actegy , Ltd. | 2016-03-31 | Traditional | PDF ↗ |
| K151722 | Slim UP ULTRA | Aime Medical, Inc. | 2016-03-18 | Traditional | PDF ↗ |
| K151903 | Slendertone connect Abs | Bio-Medical Research, Ltd. | 2015-11-06 | Traditional | PDF ↗ |
| K150078 | PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application) | Smartmissimo Technologies Pte, Ltd. | 2015-09-30 | Traditional | PDF ↗ |
| K143737 | EM25 - glute toning device | Hivox Biotek, Inc. | 2015-07-27 | Traditional | PDF ↗ |
| K141919 | VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR | Ad Rem Technology Sarl | 2015-06-16 | Traditional | PDF ↗ |
| K142055 | GYMFORM ABS & CORE | Well Brain International , Ltd. | 2015-05-11 | Traditional | PDF ↗ |
| K143551 | Compex Wireless USA | Djo, LLC | 2015-04-28 | Traditional | PDF ↗ |
| K143207 | Revitive IX (OTC) | Actegy , Ltd. | 2015-03-23 | Traditional | PDF ↗ |
| K143059 | TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator) | Tone-A-Matic International, Inc. | 2015-01-26 | Traditional | PDF ↗ |
| K141921 | HIVOX SPOPAD EMS | Hivox Biotek, Inc. | 2015-01-16 | Traditional | PDF ↗ |
| K133225 | E-FIT EF-1280 EMS MACHINE | Fit-Pro Kft , Ltd. | 2014-10-24 | Traditional | PDF ↗ |
| K133108 | FIT BELT | Hong Qiangxing (Shenzhen) Electronics Limited | 2014-08-05 | Traditional | PDF ↗ |
| K133965 | OTC EMS STIMULATOR | Shenzhen Dongdixin Technology Co., Ltd. | 2014-06-16 | Traditional | PDF ↗ |
| K134001 | FIREFLY | Firstkind Limited | 2014-05-15 | Traditional | PDF ↗ |
| K132179 | ARASYS | Ion Genius, Inc. | 2014-04-28 | Traditional | PDF ↗ |
| K130723 | FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL | Famidoc Technology Co., Ltd. | 2014-02-07 | Traditional | PDF ↗ |
| K122393 | TG-BODY MI&BODY S-TRAINER | Miga Medical Co., Ltd. | 2013-12-10 | Traditional | PDF ↗ |
| K130074 | GYMFORM ABS-A-ROUND | Well Brain International , Ltd. | 2013-08-15 | Traditional | PDF ↗ |
| K123075 | BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E | Well-Life Healthcare Limited | 2013-07-11 | Abbreviated | PDF ↗ |
| K123158 | ION MAGNUM GENIUS | Ion Genius, Inc. | 2013-06-21 | Traditional | PDF ↗ |
| K131291 | TORC BODY | Johari Digital Healthcare , Ltd. | 2013-06-14 | Special | PDF ↗ |
| K121719 | SM TENS & PMS | Hong Qiangxing (Shenzhen) Electronics Limited | 2013-05-10 | Traditional | PDF ↗ |
| K122414 | AB COMMAND DUAL CHANNEL FITNESS BELT | Leto Enterprises Incorporation | 2012-12-21 | Special | PDF ↗ |
| K111781 | GYMFORM DUAL FLEX BELT MODEL WB-162 | Well Brain International , Ltd. | 2012-07-11 | Traditional | PDF ↗ |
| K111476 | CONTOUR TECHNOLOGY MUSCLE STIMULATOR | Contour Technology | 2012-05-23 | Traditional | PDF ↗ |
| K110057 | MINI MASSEUSE | Mj Specialty Retail | 2011-10-28 | Traditional | PDF ↗ |
| K102933 | GEM-TONE BODY TRAINING SYSTEM | Gemore Technology Co, Ltd. | 2011-09-02 | Traditional | PDF ↗ |
| K102926 | GEMORE MUSCLE CONDITIONER; | Gemore Technology Co, Ltd. | 2011-08-25 | Traditional | PDF ↗ |
| K102786 | WELL-LIFE OTC EMS SYSTEM | Well-Life Healthcare Limited | 2011-07-01 | Traditional | PDF ↗ |
| K102295 | X2ABS DUAL CHANNEL FITNESS BELT | Leto Enterprises Incorporation | 2011-02-18 | Traditional | PDF ↗ |
| K093999 | ARP POV SPORT | Arp Manufacturing, Inc. | 2010-08-10 | Traditional | PDF ↗ |
| K100556 | SLENDERTONE FLEX MAX, MODEL 517 US | Bio-Medical Research, Ltd. | 2010-08-02 | Traditional | PDF ↗ |
| K092476 | SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4M | Sport-Elec | 2010-05-07 | Traditional | PDF ↗ |
| K100320 | SLENDERTONE SYSTEM ULTRA MODEL E70/X70 | Bio-Medical Research, Ltd. | 2010-05-05 | Special | PDF ↗ |
| K092142 | SPORT-ELEC BODY CONTROL SYSTEM BS | Sport-Elec | 2010-02-05 | Traditional | PDF ↗ |
| K093368 | BUTTERFLY TONER MODEL GYM070 | Global Marketing Partners Dba Gymmax USA | 2010-01-27 | Traditional | PDF ↗ |
| K091865 | SPORT-ELEC BODY CONTROL SYSTEM | Sport-Elec | 2009-11-13 | Traditional | PDF ↗ |
| K091833 | GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE. | Gemore Technology Co, Ltd. | 2009-10-16 | Traditional | PDF ↗ |
| K081998 | H-WAVE SPORT | Electronic Waveform Laboratory, Inc. | 2009-07-09 | Traditional | PDF ↗ |
| K083140 | COMPEX SPORT PLUS | Chattanooga Group | 2009-02-09 | Traditional | PDF ↗ |
| K083164 | SYSTEM-ARMS, MODELS 390, X60 | Bio-Medical Research, Ltd. | 2008-12-16 | Special | PDF ↗ |
| K081026 | BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5 | Sport-Elec S.A. | 2008-11-05 | Traditional | PDF ↗ |
| K071666 | SLENDERTONE ENERVIVE, MODEL 561 | Bio-Medical Research Corp. | 2008-03-12 | Traditional | PDF ↗ |
| K072168 | OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412 | Well-Life Healthcare Limited | 2007-12-19 | Traditional | PDF ↗ |
| K072553 | SYSTEM-ARMS, MODEL 390,E60 | Bio-Medical Research, Ltd. | 2007-12-14 | Traditional | PDF ↗ |
| K072294 | SYSTEM-MINI, MODELS: 390, E30 | Bio-Medical Research, Ltd. | 2007-10-25 | Special | PDF ↗ |
| K061914 | SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS | Sport-Elec S.A. | 2007-07-26 | Traditional | PDF ↗ |
| K061632 | GLOBUS PREMIUM MUSCLE STIMULATOR | Domino S.R.L. | 2007-04-30 | Traditional | PDF ↗ |
| K070142 | SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20 | Bio-Medical Research Corp. | 2007-03-23 | Traditional | PDF ↗ |
| K062439 | POWERTONE, MODEL PT-11 | Johari Digital Healthcare , Ltd. | 2007-01-08 | Traditional | PDF ↗ |
| K052969 | SLENDERTONE GYMBODY, MODEL 512-01 | Bio-Medical Research, Ltd. | 2005-11-16 | Special | PDF ↗ |
| K031611 | P4-FITNESS | Valmed Corp. | 2004-09-29 | Traditional | PDF ↗ |
| K030708 | SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515 | Bio-Medical Research, Ltd. | 2003-06-25 | Traditional | PDF ↗ |
| K022855 | SLENDERTONE FLEX BOTTOM & THIGH TONING SYSTEM, TYPE 511 | Bio-Medical Research, Ltd. | 2003-03-06 | Traditional | PDF ↗ |
| K020429 | AB BELT PRO | The Dezac Group | 2002-09-13 | Traditional | PDF ↗ |
| K020427 | AB BELT | The Dezac Group | 2002-09-13 | Traditional | PDF ↗ |
| K011880 | COMPEX SPORT | Compex S.A. | 2002-04-17 | Traditional | PDF ↗ |
| K010335 | SLENDERTONE FLEX, MODEL, 512 | Bio-Medical Research, Ltd. | 2001-09-27 | Traditional | PDF ↗ |
Product code NGX · Class II · Physical Medicine. Data: openFDA.