Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- MOCCushion, Flotation, Therapeutic2Product Code
- IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat2Product Code
- IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat2Product Code
- IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat2Product Code
- QOLElectroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser2Product Code
- QRAVirtual Reality Behavioral Therapy Device For Pain Relief2Product Code
- BXBExerciser, Powered1Product Code
- EGJDevice, Iontophoresis, Other Uses2Product Code
- HPHDiathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat3Product Code
- IKWUtensil, Homemaking1Product Code
- IKXAid, Transfer1Product Code
- IKZBed, Patient Rotation, Powered2Product Code
- ILCUtensil, Eating1Product Code
- ILDAdaptor, Dressing1Product Code
- ILJBath, Hydro-Massage2Product Code
- ILKTransport, Patient, Powered2Product Code
- ILMBath, Sitz, Powered2Product Code
- ILOPack, Hot Or Cold, Water Circulating2Product Code
- ILSAdaptor, Hygiene1Product Code
- ILTAdaptor, Recreational1Product Code
- ILWAdaptor, Grooming1Product Code
- ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat2Product Code
- ILYLamp, Infrared, Therapeutic Heating2Product Code
- ILZAccessories, Traction1Product Code
- IMAPack, Heat, Moist1Product Code
- IMBCabinet, Moist Steam2Product Code
- IMCBath, Paraffin2Product Code
- IMDPack, Hot Or Cold, Disposable1Product Code
- IMEPack, Hot Or Cold, Reusable1Product Code
- IMFUnit, Chilling1Product Code
- INXBed, Air Fluidized2Product Code
- INYBed, Patient Rotation, Manual1Product Code
- IOADiathermy, Microwave, For Use In Applying Therapeutic Deep Heat2Product Code
- IOBLamp, Infrared, Non Heating2Product Code
- IODComponents, Exercise1Product Code
- IOEBars, Parallel, Exercise1Product Code
- IOGTreadmill, Mechanical1Product Code
- IOLTreadmill, Powered1Product Code
- IONExerciser, Non-Measuring1Product Code
- IOQBed, Flotation Therapy, Powered2Product Code
- IPFStimulator, Muscle, Powered2Product Code
- IRNDevice, Warning, Overload, External Limb, Powered2Product Code
- IROVibrator, Therapeutic1Product Code
- IRPMassager, Powered Inflatable Tube2Product Code
- IRQUnit, Heating, Powered1Product Code
- IRRBars, Parallel, Powered1Product Code
- IRSHead Halter, Traction1Product Code
- IRTPad, Heating, Powered2Product Code
- ISAMassager, Therapeutic, Electric1Product Code
- ISDExerciser, Measuring2Product Code
- ITHEquipment, Traction, Powered2Product Code
- JFAExerciser, Finger, Powered1Product Code
- JFBTable, Physical Therapy, Multi Function2Product Code
- KNLBoard, Scooter, Prone1Product Code
- KNMDevice, Pressure Applying1Product Code
- KTBDevice, Iontophoresis, Specific Uses2Product Code
- KTCBath, Sitz, Nonpowered1Product Code
- LBGDevice, Fluidized Therapy, Dry Heat2Product Code
- LSBUnit, Fluidotherapy2Product Code
- LXFDiathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat3Product Code
- LXJInteractive Rehabilitation Exercise Devices2Product Code
- LYGMassager, Therapeutic, Manual1Product Code
- MPOInfant Heel Warmer (Chemical Heat Pack)1Product Code
- NGXStimulator, Muscle, Powered, For Muscle Conditioning2Product Code
- K251594truFlex2Cleared 510(K)
- K251706TENS and EMS Unit2Cleared 510(K)
- K251378CoolTone2Cleared 510(K)
- K251746Pure Impact2Cleared 510(K)
- K2507593 in 1 TENS UNIT2Cleared 510(K)
- K242926XBody Go USA, XBody Pro USA2Cleared 510(K)
- K250038Muscle Stimulator Device (PZ-100)2Cleared 510(K)
- K243165Limfa Therapy System (Limfa Therapy)2Cleared 510(K)
- K250146SofWave System2Cleared 510(K)
- K243763Wireless TENS & EMS Unit2Cleared 510(K)
- K241601EMS (FlexPulse, MagnaCore, Magnetika)2Cleared 510(K)
- K243511OTC TENS & EMS Unit2Cleared 510(K)
- K233770Pepper EMS Training System2Cleared 510(K)
- K242787Tens & Ems Device (TU1080)2Cleared 510(K)
- K232982EMS Sculpt Machine2Cleared 510(K)
- K242186Neo Sculptor (OF-NEO001)2Cleared 510(K)
- K241685SofWave System2Cleared 510(K)
- K240347PTG-052Cleared 510(K)
- K230711Pain Therapy Device(Model: P.T.S-X)2Cleared 510(K)
- K232181Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)2Cleared 510(K)
- K232409Electromagnetic Stimulation Systems2Cleared 510(K)
- K233070Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)2Cleared 510(K)
- K231789Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)2Cleared 510(K)
- K222400Coresculpt & Magsculpt2Cleared 510(K)
- K233035Electronic Muscle Stimulator (Model MP01)2Cleared 510(K)
- K233492EMS Neck Massager2Cleared 510(K)
- K233470DEKA LILY2Cleared 510(K)
- K230024HI-EMT MAGSHAPE2Cleared 510(K)
- K220938Nova HD+2Cleared 510(K)
- K231318Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)2Cleared 510(K)
- K231136Fitness Belt (Model: KLT-07)2Cleared 510(K)
- K231368Bemer Therapy System Evo2Cleared 510(K)
- K230261Gnesis EMS Plus2Cleared 510(K)
- K222875Powered Muscle Stimulator (Model name:MagGraver F200)2Cleared 510(K)
- K222386Visionbody2Cleared 510(K)
- K223797Neuro20 Pro System2Cleared 510(K)
- K221200XBody Go USA, XBody Pro USA2Cleared 510(K)
- K212866truSculpt flex2Cleared 510(K)
- K213748CoreLevee2Cleared 510(K)
- K221498Miha Bodytec II2Cleared 510(K)
- K211298WiEMSpro2Cleared 510(K)
- K212413I-Motion2Cleared 510(K)
- K220601CoolTone2Cleared 510(K)
- K210825Revitive Medic Coach (Model Number 5575AQ)2Cleared 510(K)
- K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)2Cleared 510(K)
- K212948Pain 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)2Cleared 510(K)
- K200545Legend Pro DMA2Cleared 510(K)
- K202148E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)2Cleared 510(K)
- K202638Pain Therapy Device2Cleared 510(K)
- K201257MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)2Cleared 510(K)
- K201975miha bodytec II2Cleared 510(K)
- K203513SLENDERTONE Evolve Abs, Type 7352Cleared 510(K)
- K210174BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set2Cleared 510(K)
- K202653Gymform Total ABS2Cleared 510(K)
- K200382BTL-703-22Cleared 510(K)
- K201239NuEra Tight Family, EMS Model2Cleared 510(K)
- K201354TENS & PMS2Cleared 510(K)
- K201653Compex Sport Elite 3.02Cleared 510(K)
- K201845Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)2Cleared 510(K)
- K182020Portable Electro-Stimulation Therapy Device2Cleared 510(K)
- K191938FitRelief TENS&EMS Wireless Device2Cleared 510(K)
- K201131firefly T-22Cleared 510(K)
- K192887Revitive Medic Plus, Revitive Advanced 22Cleared 510(K)
- K192039Torc Body2Cleared 510(K)
- K190966Katalyst Training System2Cleared 510(K)
- K192161FastFit EMS System2Cleared 510(K)
- K192940CoolTone2Cleared 510(K)
- K192264HIVOX Spopad EMS SP-911, SP-9212Cleared 510(K)
- K191181NXPRO Neuromuscular Electrical Stimulation Device2Cleared 510(K)
- K183103EMS Belt (Model MC0485)2Cleared 510(K)
- K182794BionicGym Powered Muscle Stimulator2Cleared 510(K)
- K190924Revitive Medic Plus, Revitive Advanced 22Cleared 510(K)
- K190456BTL 799-2L2Cleared 510(K)
- K182963emFieldPro2Cleared 510(K)
- K182519Miha Bodytec II2Cleared 510(K)
- K181419FLIX-EMS2Cleared 510(K)
- K190038Xbody Newave USA2Cleared 510(K)
- K183454Tyece OTC EMS System2Cleared 510(K)
- K182440Body System2Cleared 510(K)
- K181955WiEMSpro2Cleared 510(K)
- K180688SLENDERTONE CoreFit Abs 8, Type 7342Cleared 510(K)
- K182106BTL 799-2T2Cleared 510(K)
- K181728Muscle Trainer2Cleared 510(K)
- K181199Katalyst Mark 1 Muscle Stimulation System Model 22Cleared 510(K)
- K180813BTL 799-22Cleared 510(K)
- K180279Silk'n MODEL H5003 device2Cleared 510(K)
- K172876PowerDot PD-01M2Cleared 510(K)
- K172241Tyece OTC EMS System, Model EM352Cleared 510(K)
- K171035Katalyst Mark 1 Muscle Stimulation System2Cleared 510(K)
- K162744Everyway OTC EMS, Model EV-8052Cleared 510(K)
- K171092XiniWave II Model ECS322P2Cleared 510(K)
- K170918Compex Sport Elite2Cleared 510(K)
- K170903Compex Wireless USA2Cleared 510(K)
- K160323FlowKeepers2Cleared 510(K)
- K151834BEMER Classic Set, BEMER Pro-Set2Cleared 510(K)
- K163165AM-1002Cleared 510(K)
- K152420AK Body Toning Device2Cleared 510(K)
- K161974SLENDERTONE® Connect Abs, Type 5702Cleared 510(K)
- K152480Revitive Medic; Revitive MV; Revitive LV2Cleared 510(K)
- K151722Slim UP ULTRA2Cleared 510(K)
- K151903Slendertone connect Abs2Cleared 510(K)
- K150078PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)2Cleared 510(K)
- K143737EM25 - glute toning device2Cleared 510(K)
- K141919VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR2Cleared 510(K)
- K142055GYMFORM ABS & CORE2Cleared 510(K)
- K143551Compex Wireless USA2Cleared 510(K)
- K143207Revitive IX (OTC)2Cleared 510(K)
- K143059TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator)2Cleared 510(K)
- K141921HIVOX SPOPAD EMS2Cleared 510(K)
- K133225E-FIT EF-1280 EMS MACHINE2Cleared 510(K)
- K133108FIT BELT2Cleared 510(K)
- K133965OTC EMS STIMULATOR2Cleared 510(K)
- K134001FIREFLY2Cleared 510(K)
- K132179ARASYS2Cleared 510(K)
- K130723FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL2Cleared 510(K)
- K122393TG-BODY MI&BODY S-TRAINER2Cleared 510(K)
- K130074GYMFORM ABS-A-ROUND2Cleared 510(K)
- K123075BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E2Cleared 510(K)
- K123158ION MAGNUM GENIUS2Cleared 510(K)
- K131291TORC BODY2Cleared 510(K)
- K121719SM TENS & PMS2Cleared 510(K)
- K122414AB COMMAND DUAL CHANNEL FITNESS BELT2Cleared 510(K)
- K111781GYMFORM DUAL FLEX BELT MODEL WB-1622Cleared 510(K)
- K111476CONTOUR TECHNOLOGY MUSCLE STIMULATOR2Cleared 510(K)
- K110057MINI MASSEUSE2Cleared 510(K)
- K102933GEM-TONE BODY TRAINING SYSTEM2Cleared 510(K)
- K102926GEMORE MUSCLE CONDITIONER;2Cleared 510(K)
- K102786WELL-LIFE OTC EMS SYSTEM2Cleared 510(K)
- K102295X2ABS DUAL CHANNEL FITNESS BELT2Cleared 510(K)
- K093999ARP POV SPORT2Cleared 510(K)
- K100556SLENDERTONE FLEX MAX, MODEL 517 US2Cleared 510(K)
- K092476SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4M2Cleared 510(K)
- K100320SLENDERTONE SYSTEM ULTRA MODEL E70/X702Cleared 510(K)
- K092142SPORT-ELEC BODY CONTROL SYSTEM BS2Cleared 510(K)
- K093368BUTTERFLY TONER MODEL GYM0702Cleared 510(K)
- K091865SPORT-ELEC BODY CONTROL SYSTEM2Cleared 510(K)
- K091833GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE.2Cleared 510(K)
- K081998H-WAVE SPORT2Cleared 510(K)
- K083140COMPEX SPORT PLUS2Cleared 510(K)
- K083164SYSTEM-ARMS, MODELS 390, X602Cleared 510(K)
- K081026BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT52Cleared 510(K)
- K071666SLENDERTONE ENERVIVE, MODEL 5612Cleared 510(K)
- K072168OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-24122Cleared 510(K)
- K072553SYSTEM-ARMS, MODEL 390,E602Cleared 510(K)
- K072294SYSTEM-MINI, MODELS: 390, E302Cleared 510(K)
- K061914SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS2Cleared 510(K)
- K061632GLOBUS PREMIUM MUSCLE STIMULATOR2Cleared 510(K)
- K070142SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E202Cleared 510(K)
- K062439POWERTONE, MODEL PT-112Cleared 510(K)
- K052969SLENDERTONE GYMBODY, MODEL 512-012Cleared 510(K)
- K031611P4-FITNESS2Cleared 510(K)
- K030708SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 5152Cleared 510(K)
- K022855SLENDERTONE FLEX BOTTOM & THIGH TONING SYSTEM, TYPE 5112Cleared 510(K)
- K020427AB BELT2Cleared 510(K)
- K020429AB BELT PRO2Cleared 510(K)
- K011880COMPEX SPORT2Cleared 510(K)
- K010335SLENDERTONE FLEX, MODEL, 5122Cleared 510(K)
- NHNPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy2Product Code
- NYYStimulator, Muscle, Powered, With Limited Output, For Rehabilitation2Product Code
- NYZStimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning2Product Code
- OMWAdhesive Backed Thermal Skin Patches1Product Code
- OSDMassager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature2Product Code
- PCDPowered Stairway Chair Lift2Product Code
- PFWStationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat2Product Code
- PHWCold Pack And Vibrating Massager1Product Code
- PKSExerciser, Non-Measuring For Stroke Rehabilitation1Product Code
- PQYNonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain2Product Code
- QKCInteractive Rehabilitation Exercise Device, Prescription Use2Product Code
- QKDMassager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use2Product Code
- QTCAdult Portable Bed Rails For Medical Purposes1Product Code
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
CoolTone
- Page Type
- Cleared 510(K)
- 510(k) Number
- K220601
- 510(k) Type
- Special
- Applicant
- Zimmer MedizinSysteme GmbH
- Country
- Germany
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/1/2022
- Days to Decision
- 30 days
- Submission Type
- Summary