Product code NGX— Physical Medicine
CoolTone
- Classification name
- Stimulator, Muscle, Powered, For Muscle Conditioning
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Total cleared
- 163
- First cleared
- Most recent
Clearances under product code NGX — page 2
101–163 of 163- K151834 — BEMER Classic Set, BEMER Pro-Set
- K163165 — AM-100
- K152420 — AK Body Toning Device
- K161974 — SLENDERTONE® Connect Abs, Type 570
- K152480 — Revitive Medic; Revitive MV; Revitive LV
- K151722 — Slim UP ULTRA
- K151903 — Slendertone connect Abs
- K150078 — PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)
- K143737 — EM25 - glute toning device
- K141919 — VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR
- K142055 — GYMFORM ABS & CORE
- K143551 — Compex Wireless USA
- K143207 — Revitive IX (OTC)
- K143059 — TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator)
- K141921 — HIVOX SPOPAD EMS
- K133225 — E-FIT EF-1280 EMS MACHINE
- K133108 — FIT BELT
- K133965 — OTC EMS STIMULATOR
- K134001 — FIREFLY
- K132179 — ARASYS
- K130723 — FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL
- K122393 — TG-BODY MI&BODY S-TRAINER
- K130074 — GYMFORM ABS-A-ROUND
- K123075 — BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E
- K123158 — ION MAGNUM GENIUS
- K131291 — TORC BODY
- K121719 — SM TENS & PMS
- K122414 — AB COMMAND DUAL CHANNEL FITNESS BELT
- K111781 — GYMFORM DUAL FLEX BELT MODEL WB-162
- K111476 — CONTOUR TECHNOLOGY MUSCLE STIMULATOR
- K110057 — MINI MASSEUSE
- K102933 — GEM-TONE BODY TRAINING SYSTEM
- K102926 — GEMORE MUSCLE CONDITIONER
- K102786 — WELL-LIFE OTC EMS SYSTEM
- K102295 — X2ABS DUAL CHANNEL FITNESS BELT
- K093999 — ARP POV SPORT
- K100556 — SLENDERTONE FLEX MAX, MODEL 517 US
- K092476 — SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4M
- K100320 — SLENDERTONE SYSTEM ULTRA MODEL E70/X70
- K092142 — SPORT-ELEC BODY CONTROL SYSTEM BS
- K093368 — BUTTERFLY TONER MODEL GYM070
- K091865 — SPORT-ELEC BODY CONTROL SYSTEM
- K091833 — GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE.
- K081998 — H-WAVE SPORT
- K083140 — COMPEX SPORT PLUS
- K083164 — SYSTEM-ARMS, MODELS 390, X60
- K081026 — BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5
- K071666 — SLENDERTONE ENERVIVE, MODEL 561
- K072168 — OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412
- K072553 — SYSTEM-ARMS, MODEL 390,E60
- K072294 — SYSTEM-MINI, MODELS: 390, E30
- K061914 — SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS
- K061632 — GLOBUS PREMIUM MUSCLE STIMULATOR
- K070142 — SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20
- K062439 — POWERTONE, MODEL PT-11
- K052969 — SLENDERTONE GYMBODY, MODEL 512-01
- K031611 — P4-FITNESS
- K030708 — SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515
- K022855 — SLENDERTONE FLEX BOTTOM & THIGH TONING SYSTEM, TYPE 511
- K020427 — AB BELT
- K020429 — AB BELT PRO
- K011880 — COMPEX SPORT
- K010335 — SLENDERTONE FLEX, MODEL, 512
Data sourced from openFDA. This site is unofficial and independent of the FDA.