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162 FDA 510(k) clearances · Product code

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RecordFirmDate
AM-100 (K163165)BTL Industries, Inc.2017-02-16
AK Body Toning Device (K152420)Ak Beauty Enterprises, LLC2016-12-01
SLENDERTONEĀ® Connect Abs, Type 570 (K161974)Bio-Medical Research, Ltd.2016-11-01
Revitive Medic; Revitive MV; Revitive LV (K152480)Actegy , Ltd.2016-03-31
Slim UP ULTRA (K151722)Aime Medical, Inc.2016-03-18
Slendertone connect Abs (K151903)Bio-Medical Research, Ltd.2015-11-06
PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application) (K150078)Smartmissimo Technologies Pte, Ltd.2015-09-30
EM25 - glute toning device (K143737)Hivox Biotek, Inc.2015-07-27
VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR (K141919)Ad Rem Technology Sarl2015-06-16
GYMFORM ABS & CORE (K142055)Well Brain International , Ltd.2015-05-11
Compex Wireless USA (K143551)Djo, LLC2015-04-28
Revitive IX (OTC) (K143207)Actegy , Ltd.2015-03-23
TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator) (K143059)Tone-A-Matic International, Inc.2015-01-26
HIVOX SPOPAD EMS (K141921)Hivox Biotek, Inc.2015-01-16
E-FIT EF-1280 EMS MACHINE (K133225)Fit-Pro Kft , Ltd.2014-10-24
FIT BELT (K133108)Hong Qiangxing (Shenzhen) Electronics Limited2014-08-05
OTC EMS STIMULATOR (K133965)Shenzhen Dongdixin Technology Co., Ltd.2014-06-16
FIREFLY (K134001)Firstkind Limited2014-05-15
ARASYS (K132179)Ion Genius, Inc.2014-04-28
FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL (K130723)Famidoc Technology Co., Ltd.2014-02-07
TG-BODY MI&BODY S-TRAINER (K122393)Miga Medical Co., Ltd.2013-12-10
GYMFORM ABS-A-ROUND (K130074)Well Brain International , Ltd.2013-08-15
BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E (K123075)Well-Life Healthcare Limited2013-07-11
ION MAGNUM GENIUS (K123158)Ion Genius, Inc.2013-06-21
TORC BODY (K131291)Johari Digital Healthcare , Ltd.2013-06-14
SM TENS & PMS (K121719)Hong Qiangxing (Shenzhen) Electronics Limited2013-05-10
AB COMMAND DUAL CHANNEL FITNESS BELT (K122414)Leto Enterprises Incorporation2012-12-21
GYMFORM DUAL FLEX BELT MODEL WB-162 (K111781)Well Brain International , Ltd.2012-07-11
CONTOUR TECHNOLOGY MUSCLE STIMULATOR (K111476)Contour Technology2012-05-23
MINI MASSEUSE (K110057)Mj Specialty Retail2011-10-28
GEM-TONE BODY TRAINING SYSTEM (K102933)Gemore Technology Co, Ltd.2011-09-02
GEMORE MUSCLE CONDITIONER; (K102926)Gemore Technology Co, Ltd.2011-08-25
WELL-LIFE OTC EMS SYSTEM (K102786)Well-Life Healthcare Limited2011-07-01
X2ABS DUAL CHANNEL FITNESS BELT (K102295)Leto Enterprises Incorporation2011-02-18
ARP POV SPORT (K093999)Arp Manufacturing, Inc.2010-08-10
SLENDERTONE FLEX MAX, MODEL 517 US (K100556)Bio-Medical Research, Ltd.2010-08-02
SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4M (K092476)Sport-Elec2010-05-07
SLENDERTONE SYSTEM ULTRA MODEL E70/X70 (K100320)Bio-Medical Research, Ltd.2010-05-05
SPORT-ELEC BODY CONTROL SYSTEM BS (K092142)Sport-Elec2010-02-05
BUTTERFLY TONER MODEL GYM070 (K093368)Global Marketing Partners Dba Gymmax USA2010-01-27
SPORT-ELEC BODY CONTROL SYSTEM (K091865)Sport-Elec2009-11-13
GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE. (K091833)Gemore Technology Co, Ltd.2009-10-16
H-WAVE SPORT (K081998)Electronic Waveform Laboratory, Inc.2009-07-09
COMPEX SPORT PLUS (K083140)Chattanooga Group2009-02-09
SYSTEM-ARMS, MODELS 390, X60 (K083164)Bio-Medical Research, Ltd.2008-12-16
BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5 (K081026)Sport-Elec S.A.2008-11-05
SLENDERTONE ENERVIVE, MODEL 561 (K071666)Bio-Medical Research Corp.2008-03-12
OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412 (K072168)Well-Life Healthcare Limited2007-12-19
SYSTEM-ARMS, MODEL 390,E60 (K072553)Bio-Medical Research, Ltd.2007-12-14
SYSTEM-MINI, MODELS: 390, E30 (K072294)Bio-Medical Research, Ltd.2007-10-25
SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS (K061914)Sport-Elec S.A.2007-07-26
GLOBUS PREMIUM MUSCLE STIMULATOR (K061632)Domino S.R.L.2007-04-30
SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20 (K070142)Bio-Medical Research Corp.2007-03-23
POWERTONE, MODEL PT-11 (K062439)Johari Digital Healthcare , Ltd.2007-01-08
SLENDERTONE GYMBODY, MODEL 512-01 (K052969)Bio-Medical Research, Ltd.2005-11-16
P4-FITNESS (K031611)Valmed Corp.2004-09-29
SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515 (K030708)Bio-Medical Research, Ltd.2003-06-25
SLENDERTONE FLEX BOTTOM & THIGH TONING SYSTEM, TYPE 511 (K022855)Bio-Medical Research, Ltd.2003-03-06
AB BELT (K020427)The Dezac Group2002-09-13
AB BELT PRO (K020429)The Dezac Group2002-09-13
COMPEX SPORT (K011880)Compex S.A.2002-04-17
SLENDERTONE FLEX, MODEL, 512 (K010335)Bio-Medical Research, Ltd.2001-09-27
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