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
- K241488TrainFES Advance2Cleared 510(K)
- K240348Quantum Mitohormesis (QMT) (M2101)2Cleared 510(K)
- K240992eMVFit (MVF-10M)2Cleared 510(K)
- K240234BTL-899MS2Cleared 510(K)
- K233098MYOTouch Muscle Stimulator2Cleared 510(K)
- K232786Stimulation System (PA series, PR series, S series and Q series)2Cleared 510(K)
- K233926accufit2Cleared 510(K)
- K233485M-Wave2Cleared 510(K)
- K232937BTL-899M2Cleared 510(K)
- K230701Stim2Go2Cleared 510(K)
- K231440Combo Electrotherapy Device2Cleared 510(K)
- K223027NeuroTrigger Basic (NTB)2Cleared 510(K)
- K223802accufit2Cleared 510(K)
- K221274StarFormer, TightWave2Cleared 510(K)
- K230167BACK 42Cleared 510(K)
- K232334DEKA SIMON2Cleared 510(K)
- K213655HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)2Cleared 510(K)
- K222201Biological Feedback and Stimulation System2Cleared 510(K)
- K221958Flex-MI2Cleared 510(K)
- K220994Shoulder PacemakerTM2Cleared 510(K)
- K213197MyOnyx System2Cleared 510(K)
- K220738Motive Knee Wrap2Cleared 510(K)
- K220327geko W-32Cleared 510(K)
- K213043Levator Elite (Model LE9011)2Cleared 510(K)
- K212832TimeWaver Frequency2Cleared 510(K)
- K212762geko W-22Cleared 510(K)
- K192746MyoWorx TM202Cleared 510(K)
- K210002STELLA BIO2Cleared 510(K)
- K210674Shoulder Pacemaker2Cleared 510(K)
- K210938PowerDot PD-01MT2 Muscle Stimulator2Cleared 510(K)
- K211094Nerve and Muscle Stimulator2Cleared 510(K)
- K210604Intellihab System2Cleared 510(K)
- K210979Prelivia2Cleared 510(K)
- K210572Neurodyn V2.0, Neurodyn Aussie V2.02Cleared 510(K)
- K202031Talent-Pro Electromagnetic Stimulator2Cleared 510(K)
- K203710Storz Medical MAGNETOLITH Muscle Stimulator2Cleared 510(K)
- K201285InMode Evolve System with the Tone Applicator2Cleared 510(K)
- K210269PowerDot PD-01MT2 Muscle Stimulator2Cleared 510(K)
- K203488emField2Cleared 510(K)
- K202648Biofeedback Nerve and Muscle Stimulator2Cleared 510(K)
- K202079Physiq2Cleared 510(K)
- K202490Avid CT22Cleared 510(K)
- K200088g.Estim FES2Cleared 510(K)
- K201290Medline DeNovo 4Pro Electrical Stimulation Device2Cleared 510(K)
- K201958ETD Family of Electrotherapy Devices2Cleared 510(K)
- K193275Nerve and Muscle Stimulator2Cleared 510(K)
- K193045geko™ W-22Cleared 510(K)
- K183074TENS and EMS Stimulator, TENS Stimulator2Cleared 510(K)
- K192733RelieforMe TENS/EMS Device Model UPK-GE012Cleared 510(K)
- K192249InMode System with Tone Applicator2Cleared 510(K)
- K191113geko T-2 and geko T-3 Neuromuscular Stimulators2Cleared 510(K)
- K182163Shear Stress Therapeutics SST 30002Cleared 510(K)
- K181759PowerDot PD-01MT2Cleared 510(K)
- K181688R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator2Cleared 510(K)
- K181059geko T-3 Neuromuscular Stimulator2Cleared 510(K)
- K172381Digitimer DS7AP Constant Current Stimulator2Cleared 510(K)
- K180082geko T-2 and geko Plus R-22Cleared 510(K)
- K171978Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 102Cleared 510(K)
- K171071StimSox(TM) System2Cleared 510(K)
- K171387EMS100 Tri-Wave Combination Stimulator2Cleared 510(K)
- K163125geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators2Cleared 510(K)
- K162987FA100 SCCD (Sequential Continuous Contraction Device)2Cleared 510(K)
- K160614Xcite Clinical Station2Cleared 510(K)
- K163067CyMedica e-vive™ System; CY-10002Cleared 510(K)
- K160992HPM-60002Cleared 510(K)
- K151922StimSox(TM) System2Cleared 510(K)
- K153696Chattanooga Revolution Wireless2Cleared 510(K)
- K160299geko(TM) Plus R-2 Neuromuscular Stimulator2Cleared 510(K)
- K153224VitalStim(R) Plus Electrotherapy System2Cleared 510(K)
- K152677geko T-2 Neuromuscular Stimulator2Cleared 510(K)
- K150742Muscle Stimulation System 1102Cleared 510(K)
- K150413QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator2Cleared 510(K)
- K140467FLEX-MT +2Cleared 510(K)
- K133638GEKO2Cleared 510(K)
- K131917NEURODYN COMPACT, NEURODYN II2Cleared 510(K)
- K132284VECTRA NEO CLINICAL THERAPY SYSTEM2Cleared 510(K)
- K130691ELECTROTHERAPY DEVICE (COMBO UNIT)2Cleared 510(K)
- K130052TONE-A-MATIC2Cleared 510(K)
- K131629NEURODYN MULTIWAVE, AUSSIE SPORT2Cleared 510(K)
- K131222AMPCARE ESP THERAPY SYSTEM2Cleared 510(K)
- K132137MULTISTIM2Cleared 510(K)
- K130424STIMEL-032Cleared 510(K)
- K123354REVITIVE IX2Cleared 510(K)
- K124016EMPI PHOENIX2Cleared 510(K)
- K123642MUSCLE STIMULATION SYSTEM2Cleared 510(K)
- K120922GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT2Cleared 510(K)
- K113010FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR2Cleared 510(K)
- K113017SYS*STIM 2402Cleared 510(K)
- K112148POWERED MUSCLE STIMULATOR2Cleared 510(K)
- K112348RS-4I MUSCLE STIMULATOR2Cleared 510(K)
- K111279NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM2Cleared 510(K)
- K103738H-WAVE2Cleared 510(K)
- K100862BODYFLOW P2CH2Cleared 510(K)
- K092202ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT2Cleared 510(K)
- K102202GS 30002Cleared 510(K)
- K093324EMPI CONTINUUM2Cleared 510(K)
- K093138MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT90032Cleared 510(K)
- K100117LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR2Cleared 510(K)
- K092791KNEEHAB XP CONTROLLER, MODEL 4112Cleared 510(K)
- K093259ARP RX1002Cleared 510(K)
- K091248MAXEMS, MODELS 1000 AND 20002Cleared 510(K)
- K090532T.E.A.R. TECH32Cleared 510(K)
- K083105KNEEHAB XP CONDUCTIVE GARMENT, TYPE 4112Cleared 510(K)
- K090632COMPEX REHAB2Cleared 510(K)
- K080950STIWELL MED42Cleared 510(K)
- K071677SRT II MUSCLE STIMULATOR2Cleared 510(K)
- K070888COMBI 8 MAX2Cleared 510(K)
- K080787BIOMOVE 5000 SYSTEM2Cleared 510(K)
- K080661MODELS TENS 7000, EMS 7500 AND TWIN STIM2Cleared 510(K)
- K073361MUSCLE PAIN DEVICE (MPD)2Cleared 510(K)
- K072252VEINOPLUS NEUROMUSCULAR STIMULATOR2Cleared 510(K)
- K063642FD EMS, MODEL # D-FJ30E2Cleared 510(K)
- K071093SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 2022Cleared 510(K)
- K072795MODELS EMS 5.0, EMS 5.12Cleared 510(K)
- K071431GLOBUS GENESY 1100 STIMULATOR2Cleared 510(K)
- K071320EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-2013112Cleared 510(K)
- K070425VITALSTIM EXPERIA2Cleared 510(K)
- K062453KINGLY STAR POWERED MUSCLE STIMULATOR, MODEL KS-1382Cleared 510(K)
- K062354VECTRA GENISYS VMS FR2Cleared 510(K)
- K053285MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM2Cleared 510(K)
- K053266MYOTRAC INFINITI2Cleared 510(K)
- K050921EASYSTIM NMS-282Cleared 510(K)
- K051135AXIOM NVP85002Cleared 510(K)
- K050687AXIOM EPS80002Cleared 510(K)
- K050847IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A2Cleared 510(K)
- K050595FT2000 SEQUENCER FOR MUSCLE STIMULATOR2Cleared 510(K)
- K050046REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S2Cleared 510(K)
- K024258NEUROTECH KNEEHAB2Cleared 510(K)
- K041390DIAMOND MEDISTIM2Cleared 510(K)
- K042650BIOMOVE 30002Cleared 510(K)
- K041920INFINITY PLUS ELECTROTHERAPY SYSTEM2Cleared 510(K)
- K041063SMARTWAVE MS 20002Cleared 510(K)
- K042881PMD-2000 INTERFERENTIAL STIMULATOR2Cleared 510(K)
- K034005SDS-4I2Cleared 510(K)
- K040849MENTAMOVE2Cleared 510(K)
- K032954ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E802Cleared 510(K)
- K033174BMLS03-32Cleared 510(K)
- K041146CONTROL SOLUTIONS, INC., MODEL CS3102 HVG2Cleared 510(K)
- K031310TAI SHENG VARIOUS NEOX POWERED MUSCLE STIMULATOR2Cleared 510(K)
- K040306HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-72Cleared 510(K)
- K032955AUTOMOVE, MODEL AM8002Cleared 510(K)
- K033544ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N6072Cleared 510(K)
- K031375BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-5802Cleared 510(K)
- K031820ELECTRONIC MUSCLE MASSAGE, MODELS BE-550 AND BE-6602Cleared 510(K)
- K033140NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P2Cleared 510(K)
- K023000HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIES2Cleared 510(K)
- K032941AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE2Cleared 510(K)
- K032178RHYTHM TOUCH Q 2-WAY2Cleared 510(K)
- K030998MEDRELIEF SE SERIES, MODELS SE-50, SE-100, SE-200, SE-3002Cleared 510(K)
- K032652RS-4I MUSCLE STIMULATOR FAMILY2Cleared 510(K)
- K031427ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-12Cleared 510(K)
- K030403CEFAR REHAB 2 AND REHAB 2 PRO2Cleared 510(K)
- K020478ELECTROMEDICARIN 9002Cleared 510(K)
- K031884INTERFERENTIAL STIMULATOR, MODEL NETWAVE2Cleared 510(K)
- K024181PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM2Cleared 510(K)
- K023036CARE ETS2Cleared 510(K)
- K031017SYS*STIM 208 AND 208A2Cleared 510(K)
- K030507T.E.A.R. TECH3 MODEL #44TT032Cleared 510(K)
- K022998HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-3122Cleared 510(K)
- K023230ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 8002Cleared 510(K)
- K023001HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L2Cleared 510(K)
- K030648VECTORSURGE 5 MODEL 4702Cleared 510(K)
- K023997TENSCARE ULTIMA NMS/EMS2Cleared 510(K)
- K030254INTERFERENTIAL STIMULATOR, MODEL RTM10002Cleared 510(K)
- K021588ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS02-52Cleared 510(K)
- K023439MEDS-4 NEUROMUSCULAR STIMULATOR2Cleared 510(K)
- K023446MEDS-3 NEUROMUSCULAR STIMULATOR2Cleared 510(K)
- K024036PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-50002Cleared 510(K)
- K023347VITAL STIM2Cleared 510(K)
- K020130ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M2Cleared 510(K)
- K020750DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS2Cleared 510(K)
- K022493EMS 4002Cleared 510(K)
- K022776NESS SYSTEM2Cleared 510(K)
- K022175P4 PHYSIO2Cleared 510(K)
- K021905CLASSIC NMS2Cleared 510(K)
- K021472HMS-DHR-3 NEUROMUSCULAR STIMULATOR2Cleared 510(K)
- K014019NEUROTECH MEDISTIM PLUS, TYPE 2912Cleared 510(K)
- K013768POWERED MUSCLE STIMULATOR2Cleared 510(K)
- K021754APEX MEDICAL DIGITAL EMS TS1311, TS13122Cleared 510(K)
- K021100300 PV COMPLETE ELECTROTHERAPY SYSTEM2Cleared 510(K)
- K021763RS2MI MUSCLE STIMULATOR FAMILY2Cleared 510(K)
- K020637SELECT STIM2Cleared 510(K)
- K020684FINESUN EMS STIMULATOR2Cleared 510(K)
- K020314DIGI-PRO TENS, MODEL WL-2204 AND WL-22052Cleared 510(K)
- K011588SURETONE2Cleared 510(K)
- K013770MODIFICATION TO: WINNER ST-2 STIMULATOR2Cleared 510(K)
- K013771MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE2Cleared 510(K)
- K992099BIO SPA INTELLIGENT2Cleared 510(K)
- K013081MEDSTAR 1502Cleared 510(K)
- K012885NEUROMOVE NM9002Cleared 510(K)
- K011913SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES2Cleared 510(K)
- K000741EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODEL E-1882Cleared 510(K)
- K010749ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL2Cleared 510(K)
- K002339AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-1406002Cleared 510(K)
- K010807MUSCLE STIMULATOR SA-1002Cleared 510(K)
- K002336MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T2Cleared 510(K)
- K010745EMS 30002Cleared 510(K)
- K003433NEURO-TRAIN III (3)2Cleared 510(K)
- K003596SMITH & NEPHEW RESTIM2Cleared 510(K)
- K002410FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE2Cleared 510(K)
- K002058VECTORSURGE 5, MODEL VS-5002Cleared 510(K)
- K010665TRANSAMERICA DIGITAL EMS2Cleared 510(K)
- K003260VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 4602Cleared 510(K)
- K000808RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE2Cleared 510(K)
- K000114RS-4M+MUSCLE STIMULATOR2Cleared 510(K)
- K993420CONTROL SOLUTIONS INC, MODEL CS31012Cleared 510(K)
- K994062HMS NEUROMUSCULAR STIMULATOR2Cleared 510(K)
- K994065MS-ONE, MODEL MS-12Cleared 510(K)
- K993821VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT2Cleared 510(K)
- K991241IF80002Cleared 510(K)
- K990787TRIO 3002Cleared 510(K)
- K990697RS-4V MUSCLE STIMULATOR2Cleared 510(K)
- K984142SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, MODEL NUMBER ME 9942Cleared 510(K)
- K984114SYS STIM 294, MODEL ME 2942Cleared 510(K)
- K984113MS4002Cleared 510(K)
- K984021MS3002Cleared 510(K)
- K982828FORTE, MODELS CPS 400 STIM, CPS 200 STIM2Cleared 510(K)
- K982482HANDMASTER NMS12Cleared 510(K)
- K982388SURGI STIM2Cleared 510(K)
- K980158MYO-TRAIN V (5)2Cleared 510(K)
- K980040ELECTRONIC MUSCLE STIMULATOR - MICROSTIM J-1304D2Cleared 510(K)
- K973929NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM2Cleared 510(K)
- K980958HAKOMED ELECDT/VACUPULLS2Cleared 510(K)
- K980892HAKOMED ELECDT / PRO ELEDT SERIES2Cleared 510(K)
- K980346ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000)2Cleared 510(K)
- K980448MODEL PS-1 PENA MUSCLE STIMULATOR2Cleared 510(K)
- K973223STELLAR MODEL HS-042Cleared 510(K)
- K972997AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION2Cleared 510(K)
- K964434SD-970EMS ELECTRICAL MUSCULAR STIMULATOR2Cleared 510(K)
- K961751W.M.E. GPS 10012Cleared 510(K)
- K970847IMPULSE HVG2Cleared 510(K)
- K972055MSI MAGNA-STYM2Cleared 510(K)
- K971542ORTHO DX NEUROMUSCULAR STIMULATOR2Cleared 510(K)
- K955666EGS40002Cleared 510(K)
- K970155NEURO-TRAIN II (2)2Cleared 510(K)
- K964028SYS STIM 2262Cleared 510(K)
- K964423AXIOM INF2Cleared 510(K)
- K950550XH-1 NEUROMUSCULAR STIMULATOR2Cleared 510(K)
- K962462MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR2Cleared 510(K)
- K960457ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C2Cleared 510(K)
- K952273HANDMASTER NMS12Cleared 510(K)
- K955736STIM-82Cleared 510(K)
- K960433VST-10, VST-10/22Cleared 510(K)
- K955146AXIOM-HVG2Cleared 510(K)
- K960489ULTRA IV2Cleared 510(K)
- K960096ULTRA III2Cleared 510(K)
- K954411GALVA-5-M2Cleared 510(K)
- K951682OCTOSTIM2Cleared 510(K)
- K952680VARAPULSE-22Cleared 510(K)
- K953136RS-4M2Cleared 510(K)
- K951727Z-WATCH SYSTEM2Cleared 510(K)
- K953615FORTE ES-4002Cleared 510(K)
- K9507834000+2Cleared 510(K)
- K943007ITP-HVPC GALVANIC STIMULATOR2Cleared 510(K)
- K950617SMART WAVE GS1002Cleared 510(K)
- K946186CHAL-25002Cleared 510(K)
- K943185BX-200 SC2Cleared 510(K)
- K942195BX-400S2Cleared 510(K)
- K944935DYNATRON 2502Cleared 510(K)
- K946298BIOSTIM-HV2Cleared 510(K)
- K932075MASTERSTIM 1-42Cleared 510(K)
- K945508FX-2P NMS (2 CHANNEL PORTABLE)2Cleared 510(K)
- K945509FX-2 NMS (2CHANNEL TABLE MODEL)2Cleared 510(K)
- K945510FX-4 NMS (4CHANNEL TABLE MODEL)2Cleared 510(K)
- K940301COMPEX 22Cleared 510(K)
- K934556EMS-2502Cleared 510(K)
- K933194THE SIGNATURE SERIES, IMC IV2Cleared 510(K)
- K933196THE SIGNATURE SERIES, IC II2Cleared 510(K)
- K941049MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR2Cleared 510(K)
- K934919THE SIGNATURE SERIES, MAGNUM 1002Cleared 510(K)
- K940349NEUROMUSCULAR ELECTRICAL STIMULATOR2Cleared 510(K)
- K933653MS 25002Cleared 510(K)
- K931401EMS2Cleared 510(K)
- K932898POWERED MUSCLE STIMULATOR2Cleared 510(K)
- K926084HVGS 90002Cleared 510(K)
- K933195THE SIGNATURE SERIES, IC IV2Cleared 510(K)
- K932916GALVANIC GENERATOR MODEL IMF4150/A2Cleared 510(K)
- K932739FAST START NEUROMUSCULAR STIMULATOR2Cleared 510(K)
- K933072PCI 25002Cleared 510(K)
- K933249DYNATRON 100 PLUS2Cleared 510(K)
- K933176NEUROTECH 2000 (NT2000)2Cleared 510(K)
- K931781JACE TRI-STIM DEVICE2Cleared 510(K)
- K932764THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P)2Cleared 510(K)
- K932610PCI 40002Cleared 510(K)
- K932596NT4-PLUS2Cleared 510(K)
- K932399THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P)2Cleared 510(K)
- K926510STAODYN EMS+22Cleared 510(K)
- K926410ULTRATONE 8+ & 202Cleared 510(K)
- K926265NEURO-CARE 10002Cleared 510(K)
- K930670PHYACTION 7872Cleared 510(K)
- K924699PMP MUSCLE STIMULATOR2Cleared 510(K)
- K923498BIPHASIC UNIT2Cleared 510(K)
- K923501HIGH VOLT UNIT2Cleared 510(K)
- K925680LSI SYSTEM IV INTERFERENTIAL,MUSCLE STIMULATOR2Cleared 510(K)
- K920388RS-1 NEUROMUSCULAR STIMULATOR2Cleared 510(K)
- K920389RS-2 NEUROMUSCULAR STIMULATOR2Cleared 510(K)
- K923914IF-II (TM), MODEL 72002Cleared 510(K)
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- K913444GLOBALCARE EMS2Cleared 510(K)
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- K910801HIGH VOLTAGE PULSED GALVANIC STIMULATION APPLICATI2Cleared 510(K)
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- K902513CHALLENGE 6010 POWERED MUSCLE STIMULATOR2Cleared 510(K)
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- K901769CHALLENGE 6000 POWERED MUSCLE STIMULATOR2Cleared 510(K)
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- K821449P6S ATHLETIC2Cleared 510(K)
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- K811737BIO-TONE MODEL 42Cleared 510(K)
- K811395EMPI MODEL 710, NMS2Cleared 510(K)
- K811502STIMULATOR, FACIAL-MODELS SF-100 & 2002Cleared 510(K)
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- K800486STIM-EX 2012Cleared 510(K)
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- K791087PORTABLE PULSE GALVANIC STIMULATOR2Cleared 510(K)
- K791048STIMTECH NEUROMUSCULAR STIMULATOR, C 6002Cleared 510(K)
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- K781239MYO-STIM2Cleared 510(K)
- K781319THERAPY APPAR. 422 INTERFERENTIAL2Cleared 510(K)
- K781318DYNATRON 406 ELECTROTHERAPY APPARATUS2Cleared 510(K)
- K781315MUSCLE STIMULATION APPARATUS2Cleared 510(K)
- K781139MUSCLE STIMULATOR, ELECTRONIC2Cleared 510(K)
- K781113MUSCLE STIMULATOR, ELECTRICAL2Cleared 510(K)
- K781167STEMPLEX2Cleared 510(K)
- K781080GALVANATOR, MODEL 7702Cleared 510(K)
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- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SDS-4I
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K034005
- 510(k) Type
- Traditional
- Applicant
- SKYLARK DEVICE & SYSTEMS CO., LTD
- Country
- Taiwan
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/18/2004
- Days to Decision
- 330 days
- Submission Type
- Summary