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
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- GXOStrip, Craniosynostosis, Preformed2Product Code
- GXPMethyl Methacrylate For Cranioplasty2Product Code
- GXQDura Substitute2Product Code
- GXRCover, Burr Hole2Product Code
- GXTMonitor, Lesion Temperature2Product Code
- GWOPlate, Cranioplasty, Preformed, Alterable2Product Code
- GXCDevice, Electroconvulsive Therapy3Product Code
- GXNPlate, Cranioplasty, Preformed, Non-Alterable2Product Code
- GYZStimulator, Intracerebral/Subcortical, Implanted3Product Code
- GZAImplanted Cerebellar Stimulator3Product Code
- GZBStimulator, Spinal-Cord, Implanted (Pain Relief)2Product Code
- GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)2Product Code
- GZIStimulator, Neuromuscular, External Functional2Product Code
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief2Product Code
- K232441Unipro (K-UNIPRO-US)2Cleared 510(K)
- K241228TENSWave2Cleared 510(K)
- K222879Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)2Cleared 510(K)
- K212618iRelieve Microcurrent Pain Relief System2Cleared 510(K)
- K213802StimOnTM Pain Relief System (GM2439)2Cleared 510(K)
- K220578Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)2Cleared 510(K)
- K220503TENS device-EmeTerm 2, Model: YF-ZTY-E22Cleared 510(K)
- K202893Transcutaneous Electrical Nerve Stimulator2Cleared 510(K)
- K202186TrueRelief Device2Cleared 510(K)
- K210202BioWaveGO RX2Cleared 510(K)
- K201458Scrambler Therapy Technology (Model ST-5A)2Cleared 510(K)
- K202159actiTENS2Cleared 510(K)
- K201431OGYILI TENS/NMES Stimulator2Cleared 510(K)
- K181645StimaWELL 120MTRS2Cleared 510(K)
- K191547ReliefBand2Cleared 510(K)
- K182960ReliefBand2Cleared 510(K)
- K182025ClearUP Sinus Pain Relief2Cleared 510(K)
- K180943BioWaveGO2Cleared 510(K)
- K172478TENS device-EmeTerm, CinvStop2Cleared 510(K)
- K173233ReliefBand 1.52Cleared 510(K)
- K161091STIMPOD NMS460 Nerve Stimulator2Cleared 510(K)
- K162663WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A2Cleared 510(K)
- K160246SimulCare II(TM)2Cleared 510(K)
- K153704Strive2Cleared 510(K)
- K152676FD TENS 2090, FD TENS 20952Cleared 510(K)
- K152437BiowaveHOME Neuromodulation Pain Therapy Device2Cleared 510(K)
- K143198Synapse Transcutaneous Electrical Stimulation Device2Cleared 510(K)
- K142666Scrambler Therapy MC-5 A Device2Cleared 510(K)
- K131513SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY2Cleared 510(K)
- K133779CP RELIEF WAND2Cleared 510(K)
- K123099Best-AV2 Pro-Sport(tm)2Cleared 510(K)
- K131675BODIHEALTH SYSTEM2Cleared 510(K)
- K123958JIAJIAN POINTOSELECT DIGITAL2Cleared 510(K)
- K130919SENSUS2Cleared 510(K)
- K122948GEM-STIM COMBO STIMULATOR2Cleared 510(K)
- K121369NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR2Cleared 510(K)
- K121305STERLING MEDICAL IMPULSE 3 STIMULATOR2Cleared 510(K)
- K120398WITOUCH PRO2Cleared 510(K)
- K121184SENSUS2Cleared 510(K)
- K121578ATOM 1 (MODEL: BRC 2200)2Cleared 510(K)
- K113544ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER2Cleared 510(K)
- K120569GEMORE TENS SYSTEM2Cleared 510(K)
- K120054ULTIMA NEO2Cleared 510(K)
- K112288JIAJIAN TENS2Cleared 510(K)
- K111654FD TENS 20702Cleared 510(K)
- K112258NEUROTECH PLUS2Cleared 510(K)
- K112485H-WAVE2Cleared 510(K)
- K111645FD TENS 2050 OR SLIDE TENS MODEL FD20502Cleared 510(K)
- K102278QUADRA BLOC TENS PLUS2Cleared 510(K)
- K110350KNEEHAB XP2Cleared 510(K)
- K110390ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR2Cleared 510(K)
- K100668NEMA-ST, MODEL V1.0.22Cleared 510(K)
- K102014TENS STIMULATOR, MODELS 2800 AND 30002Cleared 510(K)
- K1003994 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A2Cleared 510(K)
- K092448HIVOX ELECTRIC STIMULATOR TENS & EMS, HD22Cleared 510(K)
- K091045SMART TENS, MODEL: D-BC05T2Cleared 510(K)
- K092990AMD 6605 TENS/NMES2Cleared 510(K)
- K090866NEUROCALM MODEL 1 AND 22Cleared 510(K)
- K083250NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS2Cleared 510(K)
- K091236MANTRA COMBO, MODEL MECS 3202Cleared 510(K)
- K091317LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK2Cleared 510(K)
- K090922EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR2Cleared 510(K)
- K090717FLEX-TENS2Cleared 510(K)
- K083822LASER TOUCHONE2Cleared 510(K)
- K081835ACTICARE IC AND TSE2Cleared 510(K)
- K082190BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 2982Cleared 510(K)
- K082057DX6605E-TENS, DX6605E-G, DX6609-G2Cleared 510(K)
- K081255SCRAMBLER ST 5 TENS DEVICE2Cleared 510(K)
- K082377TENSCARE ITOUCH MODEL(S) EASY AND PLUS2Cleared 510(K)
- K083030TENS-EMS-142Cleared 510(K)
- K083494ULTIMA FIVE2Cleared 510(K)
- K083202COMBOCARE 20002Cleared 510(K)
- K082011MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 4582Cleared 510(K)
- K082514TENS/EMS COMBO, EMS, TENS2Cleared 510(K)
- K080221EA STIMULATOR2Cleared 510(K)
- K081141COMBOCARE 20002Cleared 510(K)
- K080304PRO TENS, MODEL WL-240 RX2Cleared 510(K)
- K071120AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 0219992Cleared 510(K)
- K073008KFH ENERGY, MODEL: E12Cleared 510(K)
- K071869TENS/IF 142Cleared 510(K)
- K073438PROSTIM 1000/20002Cleared 510(K)
- K072123HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE2Cleared 510(K)
- K071878DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB2Cleared 510(K)
- K071624EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR2Cleared 510(K)
- K062003NEURO WAVE 62Cleared 510(K)
- K071951COMFY SERIES: EV-804, EV-805 & EV-8062Cleared 510(K)
- K061828LORENZ BIOTECH APTIVA, VERSION 2.132Cleared 510(K)
- K070299EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)2Cleared 510(K)
- K062616WELLNESSPRO 20102Cleared 510(K)
- K062641BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV12Cleared 510(K)
- K070474NEWLIFE SCIENCES LLC, MODEL TMR2Cleared 510(K)
- K062547QUADRA BLOC TENS, MODEL 1012Cleared 510(K)
- K052836BODIHEALTH SYSTEM2Cleared 510(K)
- K061516STAODYN MAX PRESET, MODEL 44702Cleared 510(K)
- K061650SELECT TENS, MODEL 4600S2Cleared 510(K)
- K060669MEDRELIEF ST SERIES, MODELS RT-50, ST-100, ST 150, ST-200, ST-3002Cleared 510(K)
- K061799QUADRATENS, MODEL QT-422Cleared 510(K)
- K061476ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-12Cleared 510(K)
- K052711EMJOI TENS DEVICE2Cleared 510(K)
- K060517POINTER EXCEL2Cleared 510(K)
- K060508POINTER PLUS2Cleared 510(K)
- K060246INFREX2Cleared 510(K)
- K050989AWQ-1042Cleared 510(K)
- K060368INSPIRSTAR IS02 MICROCURRENT STIMULATOR2Cleared 510(K)
- K053284MAGBODY DT-6002Cleared 510(K)
- K051128ELECTROPULSE2Cleared 510(K)
- K051020ES-1602Cleared 510(K)
- K052813FD TENS 2030, MODEL DFJ24T2Cleared 510(K)
- K052182SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S.2Cleared 510(K)
- K050174BIO-STIM KIT2Cleared 510(K)
- K050435E-STIM II2Cleared 510(K)
- K042912INTERX50002Cleared 510(K)
- K050740MICROWARE 2002Cleared 510(K)
- K042711MODEL BMLS03-72Cleared 510(K)
- K042107TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT0012Cleared 510(K)
- K041388COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-12Cleared 510(K)
- K041172BASBA E-MACHINE2Cleared 510(K)
- K042559GEM-TWIN TENS/ MODELS GM3XY/Z2Cleared 510(K)
- K040311SHIAN JIA MEEI DIGATAL PWN TENS, MODEL YW-6000/UC-332/UC-330/ST-3312Cleared 510(K)
- K041520MANTRA TENS MODEL NT32Cleared 510(K)
- K041359BODY CLOCK STIMPLUS AND STIMPLUS PRO2Cleared 510(K)
- K041575FENZIAN TREATMENT SYSTEM2Cleared 510(K)
- K041092FAST START TENS, MODEL FS 30012Cleared 510(K)
- K040512LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-24012Cleared 510(K)
- K041164L-TENS2Cleared 510(K)
- K040193MODEL GST-12Cleared 510(K)
- K023916BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 2942Cleared 510(K)
- K040253EASY MED TN-28 C2Cleared 510(K)
- K033455ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-52Cleared 510(K)
- K032003PREMIER PLUS2Cleared 510(K)
- K033857T-TECH DIGITAL, MODEL WL-22XXA SERIES2Cleared 510(K)
- K032928MEDIPHYSICS PAIN TREATMENT SYSTEM, MODEL 12Cleared 510(K)
- K032994GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)2Cleared 510(K)
- K032720GEM-STIM TENS, MODELS GM3XY AND GM3AXY2Cleared 510(K)
- K031374BESMED VARIOUS MODELS OF TENS, BE-550/BE-6602Cleared 510(K)
- K031546RAINBOW GT-4A PAIN RELIEF MACHINE2Cleared 510(K)
- K033253S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR2Cleared 510(K)
- K032055MEDS-4-INF+2Cleared 510(K)
- K032653E2752Cleared 510(K)
- K023913NEUROTECH BAXOLVE TYPE 2942Cleared 510(K)
- K023726TENS PRO 9002Cleared 510(K)
- K022849BODY CLOCK TENS N' TONE2Cleared 510(K)
- K021952HIVOX DREAMATE DM-8002Cleared 510(K)
- K022417CARE STIM2Cleared 510(K)
- K023231ELFCARE DEVICE, MODELS 314A THROUGH 314G2Cleared 510(K)
- K030537DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B2Cleared 510(K)
- K030140DUOMED, SERIES 500, (MODELS ID 500, FL 500)2Cleared 510(K)
- K021270ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-22Cleared 510(K)
- K021271ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-32Cleared 510(K)
- K023443MEDS-3 NEUROMUSCULAR STIMULATOR2Cleared 510(K)
- K023435MEDS-4 NEUROMUSCULAR STIMULATOR2Cleared 510(K)
- K021794TATUNG TMD-26AX SERIES TENS, MODELS NO. TMD-26AB TATUNG TENS (BLUE HOUSING) TMD-26AY TATUNG TENS (YELLOW HOUSING)2Cleared 510(K)
- K020020THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302)2Cleared 510(K)
- K021430SANIDAD TENS-DUO MODE GP8016N2Cleared 510(K)
- K021846804SIII; 804W; LIBRA TENS; 410; S-TENS II2Cleared 510(K)
- K022925ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-102Cleared 510(K)
- K022841ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-92Cleared 510(K)
- K022731V TENS PLUS2Cleared 510(K)
- K020749DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS2Cleared 510(K)
- K022076FIRST CHOICE & FIRST CHOICE PLUS2Cleared 510(K)
- K020712ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-42Cleared 510(K)
- K013532ULTRASTIM KIT2Cleared 510(K)
- K022405MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MIC2Cleared 510(K)
- K021496HMS-DHR-3 NEUROMUSCULAR STIMULATOR2Cleared 510(K)
- K021436TTECH MODEL 200E + TENS DEVICE2Cleared 510(K)
- K011891PANAG2Cleared 510(K)
- K014020NT MEDITENS PLUS, TYPE 2902Cleared 510(K)
- K021755APEX MEDICAL DIGITAL TENS TS1211, TS12122Cleared 510(K)
- K020803CEFAR MEDICAL AB CEFAR PRIMO2Cleared 510(K)
- K020846ULTIMA TENS XL-A12Cleared 510(K)
- K014126SANIDAD HEALTH-UP TENS MP-737252Cleared 510(K)
- K021359DIGI-PRO TENS MODEL WL-2203 AND WL-22052Cleared 510(K)
- K013210TRUWAVE2Cleared 510(K)
- K020180RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL2Cleared 510(K)
- K020437CLASSIC TENS2Cleared 510(K)
- K003744ENRAF-NONIUS ENDOMED 182 SYSTEM2Cleared 510(K)
- K020032APEX MEDICAL MINI TENS2Cleared 510(K)
- K013167MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F5002Cleared 510(K)
- K013507COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH2Cleared 510(K)
- K004008STRESS GUARD, MODEL HERDEV12Cleared 510(K)
- K012643APEX MEDICAL LCD TENS-VII2Cleared 510(K)
- K012848WINNER CM4 COMBINATION UNIT2Cleared 510(K)
- K010615CYCLOTEC AMT CTI TENS DEVICE2Cleared 510(K)
- K011017PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT2Cleared 510(K)
- K011543TENS CARE, MODEL XL-Y32Cleared 510(K)
- K010203ACCU-PULSE TENS UNIT2Cleared 510(K)
- K010295MICROSTIM 100I TENS DEVICE2Cleared 510(K)
- K002874WELL-TENS2Cleared 510(K)
- K010209ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL2Cleared 510(K)
- K001897MULTI-STIM, MODEL MS-1002Cleared 510(K)
- K010782TRANSAMERICAN TENS2Cleared 510(K)
- K002297YORAMED, MODEL T-2022Cleared 510(K)
- K003369LIFECARE COMPACT TENS DEVICE2Cleared 510(K)
- K003507MEDRELIEF2Cleared 510(K)
- K003591TENSCARE, MODEL TENS XL-22Cleared 510(K)
- K993229ANALGESIC PULSER, MODEL AP-4392Cleared 510(K)
- K003487STIMATE N601 TENS2Cleared 510(K)
- K003258MS-ONE, MODEL MS-12Cleared 510(K)
- K003231HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 32Cleared 510(K)
- K994266FDTENS 20102Cleared 510(K)
- K994265MEDISANA DIGITAL TENS2Cleared 510(K)
- K984376ENDOR 20002Cleared 510(K)
- K994387RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL2Cleared 510(K)
- K991397TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS2Cleared 510(K)
- K983907RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R2Cleared 510(K)
- K993823MED-40002Cleared 510(K)
- K9927091818 TENS UNIT2Cleared 510(K)
- K990230ELECTRO-NERVE STIMULATOR TENS, MODEL LX2Cleared 510(K)
- K982961MEDIPOINT2Cleared 510(K)
- K982173BUZBEE2Cleared 510(K)
- K982967RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R2Cleared 510(K)
- K984025CARE TENS2Cleared 510(K)
- K982321VECTRA STIM MODELS 200 AND 4002Cleared 510(K)
- K982324VECTRA PRO MODELS 2 AND 42Cleared 510(K)
- K981976ACUTRON MENTOR MODEL 9612Cleared 510(K)
- K982410SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICE2Cleared 510(K)
- K982436RELIEFBAND NST DEVICE, MODEL #'S WB-2, WB-6 AND WB-R2Cleared 510(K)
- K982221PREMIER AP2Cleared 510(K)
- K964437GB-1002 TENS WITH MASSAGE2Cleared 510(K)
- K973980ACU-STIM TENS, AP-101082T2Cleared 510(K)
- K973979MULTI-STIM TENS, AP-101081T2Cleared 510(K)
- K973978MICRO II MICROCURRENT TENS2Cleared 510(K)
- K972244NT20002Cleared 510(K)
- K980333RELIEFBAND2Cleared 510(K)
- K974497INTELECT2Cleared 510(K)
- K965244Z TECH TRANSCUTANEOUS NEURAL STIMULATION2Cleared 510(K)
- K962951MODEL HS-2 TENS DEVICE2Cleared 510(K)
- K965187SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD2Cleared 510(K)
- K961050RELIEFBAND TENS UNIT (MODIFICATION)2Cleared 510(K)
- K940954SYNAPTIC 30002Cleared 510(K)
- K970429BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T2Cleared 510(K)
- K953982SIMPLEX TENS2Cleared 510(K)
- K970203EPIX VT2Cleared 510(K)
- K963507EXTRA TENS (RI-2500) NEO TENS (RI-2000E)2Cleared 510(K)
- K970696S.P. 1002Cleared 510(K)
- K961809SHE-LI TENS STIMULATOR MODEL SL-101 RX2Cleared 510(K)
- K963729SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)2Cleared 510(K)
- K963125M AND R REUSABLE ELECTRODES (MULTIPLE)2Cleared 510(K)
- K955470ACTION POTENTIAL SIMULATION THERAPY DEVICE2Cleared 510(K)
- K961376SMART-TENS, MODEL 4562Cleared 510(K)
- K962910SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY2Cleared 510(K)
- K962332TENS/FES/NMES ELECTRODES2Cleared 510(K)
- K961749TRANSAMERICA ELECTRODE2Cleared 510(K)
- K954951TAYLOR GENERAL PURPOSE MONITORING ELECTRODE2Cleared 510(K)
- K951951FOCUS MODEL 795 UNIT2Cleared 510(K)
- K960969GALVA 5-T2Cleared 510(K)
- K951903EPIX XL TENS UNIT2Cleared 510(K)
- K954334ACUPLUS2Cleared 510(K)
- K946230ENDURA REUSABLE TENS AND NMES ELECTRODES2Cleared 510(K)
- K942631ELECTROCARE2Cleared 510(K)
- K940600STIMULATOR, NERVE, TRANSCUTANEOUS, (PAIN RELIEF) 84-GZJ2Cleared 510(K)
- K946299PGS123 AND HVS-1232Cleared 510(K)
- K941923STERILE TREATMENT ELECTRODE2Cleared 510(K)
- K933197THE SIGNATURE SERIES, M IV2Cleared 510(K)
- K944280TRANSAMERICAN CLASSIC TENS2Cleared 510(K)
- K945676GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES2Cleared 510(K)
- K933237MEDI-STIM, MODIFICATION2Cleared 510(K)
- K934051BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)2Cleared 510(K)
- K932897TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR2Cleared 510(K)
- K931079STAT-TENS2Cleared 510(K)
- K933368TENS-IT2Cleared 510(K)
- K935324THERAPEUTIC ULTRASOUND AND STIMULATOR2Cleared 510(K)
- K935395NEURON II AND MICROTENS2Cleared 510(K)
- K930102PULSATOR 50002Cleared 510(K)
- K932592BRACE NEUTRALIZER2Cleared 510(K)
- K935132HOME MICROCURRENT HMC2Cleared 510(K)
- K934619FLEXMATE2Cleared 510(K)
- K932854EZ GRIP DISPOSABLE ELECTRODES2Cleared 510(K)
- K931108EZ GRIP REUSABLE TENS/NMES ELECTRODES2Cleared 510(K)
- K932611NEUROMUSCULAR STIMULATOR2Cleared 510(K)
- K932849PMI TENS ELECTRODE2Cleared 510(K)
- K931715PURECARE AT-903 T.E.N.S.2Cleared 510(K)
- K932320NEUTRALIZER2Cleared 510(K)
- K931570COM-TENS (SINGLE MODE)2Cleared 510(K)
- K931424MAXIMA I2Cleared 510(K)
- K926326MICROCARE(TM)2Cleared 510(K)
- K923970INTEGRITY 22Cleared 510(K)
- K922202K-STIM CLEAR2Cleared 510(K)
- K930865STAODYN MAXIMA III2Cleared 510(K)
- K925821COMFORTRON2Cleared 510(K)
- K915663TENS PRO 9002Cleared 510(K)
- K925686THERA PULSE A ELECTRO NERVE STIMULATOR2Cleared 510(K)
- K925898MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUS2Cleared 510(K)
- K925729SD-602 SD MODE 11, SD-603 SD MOD 1112Cleared 510(K)
- K920266TENS MODEL 240Z2Cleared 510(K)
- K924545MICRO MODE-TRANS ELECTRICAL NEURAL STIMULATOR2Cleared 510(K)
- K923934TX-3 SD2Cleared 510(K)
- K923935SD-605 SD II PROGRAM2Cleared 510(K)
- K923298MICRO 100,200,300, & 400 TENS2Cleared 510(K)
- K922690PAIN-EEZ2Cleared 510(K)
- K920260INTELECT 600MP2Cleared 510(K)
- K921679K-DISPERSE2Cleared 510(K)
- K923255Q-SD2Cleared 510(K)
- K921828TEAM-MC II2Cleared 510(K)
- K921813MED-TENS2Cleared 510(K)
- K921110TENS2Cleared 510(K)
- K915210ELECTRO-NERVE STIMULATOR TENS MODEL MICRO PLUS-A2Cleared 510(K)
- K912381LOW BACK STRIP (OR) K-BACK2Cleared 510(K)
- K910727EXCEL MODEL 21102Cleared 510(K)
- K914813THERASTIM2Cleared 510(K)
- K914871TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL2Cleared 510(K)
- K914441MENS 2000-D2Cleared 510(K)
- K911963MEDTRONIC MODEL 90002065 MF TENS SYSTEM2Cleared 510(K)
- K913532TX 3 TENS MODIFIED2Cleared 510(K)
- K912289ULTIMA XS, MODIFICATION2Cleared 510(K)
- K901704RELIEF BAND (T.E.N.S. DEVICE)2Cleared 510(K)
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- K911814AXION 5, MODIFICATION2Cleared 510(K)
- K905672TEAM-MC2Cleared 510(K)
- K913800MEDA CROWN SERIES2Cleared 510(K)
- K913522SOLITENS MODIFIED2Cleared 510(K)
- K913594DYNEX IIIB, MODEL 890020262Cleared 510(K)
- K910244GLOBAL CARE MICRO II2Cleared 510(K)
- K912348SX90 (TM),MODEL 4800S2Cleared 510(K)
- K905526AGARRELIEF 10 TRANSCUTANEOUS ELEC NERVE STIMULATOR2Cleared 510(K)
- K910580MICROSTIM 100 MODEL 2C2Cleared 510(K)
- K902226MY-O-MATIC 5000I2Cleared 510(K)
- K905570ELECTRO-NERVE STIMULATOR TENS MODEL BIOMED 2000/A2Cleared 510(K)
- K905377ELECTRO-NERVE STIMULATOR TENS MODEL SYSTEMS 2000/A2Cleared 510(K)
- K905230ELECTRO-NEVE STIMULATOR TENS MODEL BIOMED PLUS/A2Cleared 510(K)
- K904388POINTER F-3 TENS2Cleared 510(K)
- K902102COM-TENS: A NEUROSTIMULATOR2Cleared 510(K)
- K904288MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS2Cleared 510(K)
- K904260MENS-O-MATIC 30002Cleared 510(K)
- K904258MICRO DERM2Cleared 510(K)
- K904234MENS-O-MATIC I2Cleared 510(K)
- K904235MENS-O-MATIC 20002Cleared 510(K)
- K904430MENS FREEDOM MICRO2Cleared 510(K)
- K904264MODEL SW-103 SOLITANS STIMULATOR2Cleared 510(K)
- K903394GLOBALCARE MICRO 11 AND MICROCARE (TENS)2Cleared 510(K)
- K904457DIAL-AWAY PAIN2Cleared 510(K)
- K903161MC II (TM), MODEL 7200S2Cleared 510(K)
- K903577DYNATRON 200 MICROCURRENT2Cleared 510(K)
- K903828SYNAPS (TM)2Cleared 510(K)
- K903128STIMTRAC PC, CATALOG NO. 78-85102Cleared 510(K)
- K902822MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE2Cleared 510(K)
- K896825TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR2Cleared 510(K)
- K903017MEGA-TENS DUAL CHANNEL T.E.N.S.2Cleared 510(K)
- K896408QUANTUM2Cleared 510(K)
- K901417ELECTROSTIM MST2Cleared 510(K)
- K901726LUMISCOPE MICRO 1002Cleared 510(K)
- K896787TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION2Cleared 510(K)
- K900668ACUDATA INDICATENS MODEL 5XS2Cleared 510(K)
- K900596ACUDATA INDICATENS MODEL 5A2Cleared 510(K)
- K896620NEUROTENS2Cleared 510(K)
- K896226LISS BODY STIMULATOR MODEL SBL501-M2Cleared 510(K)
- K896948ALPHA-STIM CS2Cleared 510(K)
- K883911ELECTRO-ACUSCOPE 852Cleared 510(K)
- K895289MEC-I-TRON MINI, MODEL M-22Cleared 510(K)
- K895183REBOX II (TENS)2Cleared 510(K)
- K895977ACUSOURCE 600 (TENS)2Cleared 510(K)
- K894964K-2 TENS OR MED TENS2Cleared 510(K)
- K895473DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S2Cleared 510(K)
- K895295ULTIMA XS MICROCURRENT TENS2Cleared 510(K)
- K895334TTS26002Cleared 510(K)
- K895161TTS28002Cleared 510(K)
- K895166TTS25002Cleared 510(K)
- K895211TTS2700 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR2Cleared 510(K)
- K883811ELECTRONIC PAIN RELIEVERS2Cleared 510(K)
- K891992TENZCARE STIMULATOR 68902Cleared 510(K)
- K890087ACUDATA INDICATENS MODEL 5M2Cleared 510(K)
- K894127LUMISCOPE MODEL 1000/APCC MODEL 10002Cleared 510(K)
- K891118STERLING TENS2Cleared 510(K)
- K894388ZIMMER TENS2Cleared 510(K)
- K884972TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR2Cleared 510(K)
- K892408NSD 8CS8 - TENS DEVICE2Cleared 510(K)
- K884869MODIFIED MRL NEUROPROBE SYSTEM V2Cleared 510(K)
- K890604EMPI, MODEL 489, TENS2Cleared 510(K)
- K890088ACUDATA INDICATENS MODEL 5X2Cleared 510(K)
- K885190MICRO-STIM 2002Cleared 510(K)
- K882980REBUILDER BUCKET SYSTEM2Cleared 510(K)
- K890705MEDIMOD(TM), MODEL 89002Cleared 510(K)
- K884833ULTRA 2000 (T.E.N.S.)2Cleared 510(K)
- K880744ANESTY 102Cleared 510(K)
- K883188T.E.N.S. UNIT SIGMA & TX-32Cleared 510(K)
- K884210TX-7 (TENS) (IC-1107)2Cleared 510(K)
- K883236CEFAR DUAL2Cleared 510(K)
- K884032MORGAN TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR2Cleared 510(K)
- K882154HEPAX (TENS)2Cleared 510(K)
- K874818TENSTAR2Cleared 510(K)
- K882631EMPI MODEL 727,NMS2Cleared 510(K)
- K875072MODIFIED AMANA ELECTROTHERAPEUTIC SYSTEM2Cleared 510(K)
- K880426ELECTROSTIMULATOR MODEL 8082Cleared 510(K)
- K881753ALPHA-STIM 3502Cleared 510(K)
- K882820MEDIPAC II EC (TM), MODEL 79002Cleared 510(K)
- K882943MEDA ONE-STEP2Cleared 510(K)
- K881708INDICATENS 4X42Cleared 510(K)
- K880042ACUTRON2Cleared 510(K)
- K881832DS-200 AND DS-400 T.E.N.S.2Cleared 510(K)
- K881704EASY TENS2Cleared 510(K)
- K880492INTERCEPT T.E.N.S. DEVICE2Cleared 510(K)
- K881114EMPI MODEL 989, TENS2Cleared 510(K)
- K881424PREMIER 10S (TENS)2Cleared 510(K)
- K880980SCHULDT* PC* - DUAL CHANNEL TENS2Cleared 510(K)
- K880751ULTIMA XS (TENS)2Cleared 510(K)
- K880452LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE2Cleared 510(K)
- K872704AMASTIM 20002Cleared 510(K)
- K873190MEC-I-TRON, MODEL P-12Cleared 510(K)
- K874085REBUILDER(TM)2Cleared 510(K)
- K874550TX-4(TENS) (SIGMA TENS)2Cleared 510(K)
- K874333TX-2(TENS)2Cleared 510(K)
- K873357ELECTROBLOC TRANS. ELECTRICAL NERVE BLOCK GENERA.2Cleared 510(K)
- K873420GLOBALCARE(TENS)2Cleared 510(K)
- K873484120Z(TENS)2Cleared 510(K)
- K872657ULTRAPAC II SX PLUS (TM)2Cleared 510(K)
- K872398T.E.N.S. DEVICE MODEL SPL 20002Cleared 510(K)
- K872399T.E.N.S. DEVICE MODEL SPL 2000S2Cleared 510(K)
- K871722MEDTENS(TM), MODEL NUMBER 77252Cleared 510(K)
- K871699TX-3(TENS)2Cleared 510(K)
- K871666MODEL HP (OR MODEL 1001) TRANSCUTANEOUS STIMULATOR2Cleared 510(K)
- K871396ACCULATOR 287EP2Cleared 510(K)
- K871125ELECTRO-NERVE STIMULATOR TENS MODEL B5/SKN2Cleared 510(K)
- K871126ELECTRO-NERVE STIMULATOR TENS MODEL C & B11, B11C2Cleared 510(K)
- K870666OMEGA T1002Cleared 510(K)
- K870667OMEGA T2002Cleared 510(K)
- K864370DYNATRON 1120 EPS (ELECTRICAL POINT STIMULATOR)2Cleared 510(K)
- K870168EMPI LOGIX MODEL 712 NMS, TENS2Cleared 510(K)
- K864114TENS DEVICE FOR RELIEF OF CHRONIC PAIN2Cleared 510(K)
- K862454AGAR 7K TENS INSTRUMENT2Cleared 510(K)
- K870583NEU-PULS(TENS) MODEL #2952Cleared 510(K)
- K865063UNI-PULS(TENS) MODEL #2922Cleared 510(K)
- K864968BACPAC (TM), MODEL 65002Cleared 510(K)
- K864956DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.2Cleared 510(K)
- K865048ECLIPSE+, MODEL NUMBER 77232Cleared 510(K)
- K864368SCHULDT* PLUS 8 T.E.N.S. DEVICE2Cleared 510(K)
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- K863469CODETRON TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.2Cleared 510(K)
- K862352ACCULATOR 487E2Cleared 510(K)
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- K862450MEDA 2500 T.E.N.S.2Cleared 510(K)
- K863568'MYOSTIM EX'2Cleared 510(K)
- K863567'TENSAID'2Cleared 510(K)
- K861895UNI-TENS2Cleared 510(K)
- K861894AGAR 9K TENS2Cleared 510(K)
- K861896UNI-TENS XL TENS2Cleared 510(K)
- K862355TRANS-PULSE MODEL #11032Cleared 510(K)
- K862337ULTRAPAC II SD (TM)2Cleared 510(K)
- K861119WALLANT NEUROLOGIX DUAL PUR NERVE/NEUROMUSCU STIMU2Cleared 510(K)
- K860847WALLANT NEUROLOGIX GENERAL PURPOSE TENS2Cleared 510(K)
- K852061PULSAR NEUROSTIMULATOR2Cleared 510(K)
- K861830EMPI MODEL GLS 450, TENS2Cleared 510(K)
- K861451EMPI MODEL 720 NMS, TENS2Cleared 510(K)
- K861214SKYLARK GB 10002Cleared 510(K)
- K853898SKYLARK MODEL 1001 TENS DEVICE2Cleared 510(K)
- K861709A TENS (MODEL AI-86)2Cleared 510(K)
- K860772HARIKY, MODEL GK-72Cleared 510(K)
- K861501EXER-STIM 22Cleared 510(K)
- K854316FASTENS(TM)2Cleared 510(K)
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- K854761MINIPAC PERSONAL TOUCH (TM)2Cleared 510(K)
- K853885MODEL RF-TENS-4 TRANSCUTANEOUS ELEC. NERVE STIMULA2Cleared 510(K)
- K854317MINIPAC (TM)2Cleared 510(K)
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- K853836NEURO PULSE II2Cleared 510(K)
- K853442MODEL 804 (TENS)2Cleared 510(K)
- K853719TRANSCUTANEOUS ELECT. NERVE STIMUL-MYOSTIM 4102Cleared 510(K)
- K853718TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 8042Cleared 510(K)
- K851735SYS STIM 206 MODEL ME2062Cleared 510(K)
- K853416MES-TENS(TENS)2Cleared 510(K)
- K852837ADVANCED MEDICAL PRODUCTS DR PULSE (TENS)2Cleared 510(K)
- K852836ADVANCED MEDICAL PRODUCTS MINI-M (TENS)2Cleared 510(K)
- K852838ADVANCED MEDICAL PRODUCTS MES TENS2Cleared 510(K)
- K844618BIO-TENS2Cleared 510(K)
- K851511ACCURATECARE I & ACCURATECARE II2Cleared 510(K)
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- K844212STIMTECH SD CLINICIAN 6090 #78-80552Cleared 510(K)
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- K841400NEURO PULSE2Cleared 510(K)
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- K831144ALPHA-STIM 20002Cleared 510(K)
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- K823466AUTO-TENS MODEL III DUAL CHANNEL REPLACE2Cleared 510(K)
- K823467AUTO-TENS MODEL I DISPOS. SINGLE CHAN2Cleared 510(K)
- K823465AUTO-TENS MODEL II SINGLE CHANNEL2Cleared 510(K)
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- K823497WRIGHT CARE2Cleared 510(K)
- K823299MODEL 402P SEQUENCER FOR EMPI TEMS DEV2Cleared 510(K)
- K823002DENDRITE VM-TRANSCUTANEOUS ELEC. NERVE2Cleared 510(K)
- K822929VERIL/PPR PERSONAL PAIN RELIEVER #8002Cleared 510(K)
- K822841THE EMD TENZ PAIN CONTROL SYSTEM2Cleared 510(K)
- K822854PRO MED 1002Cleared 510(K)
- K822600NEUROMEDICS ORIONS #660-012Cleared 510(K)
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- K820651MODEL 860-1 VERI/PROBE2Cleared 510(K)
- K820326BIGSTON TRANSCUTANEOUS NERVE STIMULAT2Cleared 510(K)
- K820678SYSTEM 102Cleared 510(K)
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- K813501TRANSCUTANEOUS ELEC. NERVE STIMULATOR2Cleared 510(K)
- K813100BIO-STIMULATOR, MODEL 4002Cleared 510(K)
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- K811499TENSMAX2Cleared 510(K)
- K812036NEUROGAR III2Cleared 510(K)
- K811351VERI-FIER2Cleared 510(K)
- K811939VITATRON 882Cleared 510(K)
- K811345INSIGHT2Cleared 510(K)
- K811095TRANSCUTANEOUS ELECTRICAL NERVE2Cleared 510(K)
- K810841MEDAID2Cleared 510(K)
- K811224MINISTIM2Cleared 510(K)
- K811012TENS-O-MATIC2Cleared 510(K)
- K810593NEUROPAC ULTRA I2Cleared 510(K)
- K803121MENTOR 150 TRANSCUTANEOUS NERVE STIMULA2Cleared 510(K)
- K803113MENTOR 402 TRANSCUTANEOUS ELEC. STIMULAT2Cleared 510(K)
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- K802678TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR2Cleared 510(K)
- K802507TENSMATE EMPIMODEL 99802Cleared 510(K)
- K802063SPEMBLY 9000 & 93002Cleared 510(K)
- K802227ANASTIM II TRANSCUTANEOUS ELECTRICAL2Cleared 510(K)
- K801459ELECTRO-ACUSCOPE-702Cleared 510(K)
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- K792473THERAPETTE, MODEL NO MH-1002Cleared 510(K)
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- K792522MODEL 980D TENS NEUROPACER2Cleared 510(K)
- K792474TENS 45002Cleared 510(K)
- K792311MEDTRONIC MODEL 7728 NEUROMOD2Cleared 510(K)
- K791834NURITE II VRM DUAL (ELEC. NERVE STIM.)2Cleared 510(K)
- K791833NURITE II VRM SINGLE (ELEC. NERVE STIM)2Cleared 510(K)
- K791187MODEL 810 VERI/TGS2Cleared 510(K)
- K791158STIMULATOR, ELECTRICAL NERVE2Cleared 510(K)
- K782164STIMULATOR, MODEL 1-600 ELECTRIC NERVR2Cleared 510(K)
- K790011STIMULATOR, MENTOR 100 NERVE2Cleared 510(K)
- K790189ELECTREAT MODEL 250 TRANSCUTANEOUS STIM2Cleared 510(K)
- K782127STIMULATOR, ELECTRICAL NERVE2Cleared 510(K)
- K782075STIMULATOR, MODEL 77272Cleared 510(K)
- K781829NEUROPAC ULTRA II2Cleared 510(K)
- K781670STIMULATOR, E.S.I. NEURO2Cleared 510(K)
- K781683NURITE II, SINGLE2Cleared 510(K)
- K781565ELECTRICAL NERVE STIMULATOR MODEL 60352Cleared 510(K)
- K781277STIMULATOR, NERVE, TRANSCUTANEOUS2Cleared 510(K)
- K780828NURITE II2Cleared 510(K)
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- K780444NERVTRON-RX2Cleared 510(K)
- K780186NEUROMOD STIMULATOR MODEL 37232Cleared 510(K)
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- K771885IMPORTED PAIN CONTROL DEVICE2Cleared 510(K)
- K771122VERI/CTGS MODEL 8502Cleared 510(K)
- K761053ANODYNE II-ELECTRICAL NEURO STIMULATOR2Cleared 510(K)
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- PLUThermal System For Insomnia2Product Code
- POLNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment2Product Code
- PUUTemporary Coil Embolization Assist Device2Product Code
- PVLEndoscopic Shunt Placement Kit2Product Code
- PVOLumbar Drainage Catheter Kit2Product Code
- PWEComputerized Behavioral Therapy Device For Psychiatric Disorders2Product Code
- PZRPercutaneous Nerve Stimulator For Opioid Withdrawal2Product Code
- QAKNon-Invasive Vagus Nerve Stimulator For Migraine Headache2Product Code
- QARThermal Vestibular Stimulator For Headache2Product Code
- QBCExternal Upper Limb Tremor Stimulator2Product Code
- QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder2Product Code
- QFDTens For Sinus Pain2Product Code
- QFFElectromechanical Arm For A Transcranial Magnetic Stimulation System2Product Code
- QGHElectroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder2Product Code
- QGLTranscutaneous Nerve Stimulator For Adhd2Product Code
- QGTDistal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine2Product Code
- QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety2Product Code
- QMZDigital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions2Product Code
- QQCBrain Stimulation Programming Planning Software.2Product Code
- QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder2Product Code
- OVPVibratory Counter-Stimulation2Product Code
- QVOComputerized Behavioral Therapy Device For Insomnia2Product Code
- SAPComputerized Behavioral Therapy Device For Depressive Disorders.2Product Code
- SCPComputerized Behavioral Therapy Device For Anxiety Disorders2Product Code
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K963729
- 510(k) Type
- Traditional
- Applicant
- SKYLARK DEVICE CO., LTD.
- Country
- Taiwan
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/13/1997
- Days to Decision
- 150 days
- Submission Type
- Statement