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
- GXWEchoencephalograph2Product Code
- GXXBlock, Test, Ultrasonic Scanner Calibration1Product Code
- GXYElectrode, Cutaneous2Product Code
- K243788IceCap product line2Cleared 510(K)
- K243243Delphi MCS Electrode Cap2Cleared 510(K)
- K241512Electrode Pad2Cleared 510(K)
- K242326Wave Electrode (AE02-60); Wave Electrode (AE02-50)2Cleared 510(K)
- K241160CAIs Sensor (CAIs-001)2Cleared 510(K)
- K240575WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)2Cleared 510(K)
- K242346Grass® MR Conditional/CT Cup Electrodes2Cleared 510(K)
- K240108Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01)2Cleared 510(K)
- K240884Glide (91000-GL-X)2Cleared 510(K)
- K240668Amydi-med Disposable Non-invasive EEG electrodes2Cleared 510(K)
- K232995Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe2Cleared 510(K)
- K221199Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)2Cleared 510(K)
- K231164Conductive carbon film electrode2Cleared 510(K)
- K231167Conductive Silicone Rubber Electrode2Cleared 510(K)
- K232052Ceribell Instant EEG Headband2Cleared 510(K)
- K221589Starly pad2Cleared 510(K)
- K230533Motive™ Electrode2Cleared 510(K)
- K223086Ceribell Instant EEG Headcap2Cleared 510(K)
- K222671DeltaScan Patch2Cleared 510(K)
- K222863Garment Electrodes2Cleared 510(K)
- K222252Self-adhesive Electrode2Cleared 510(K)
- K220448Disposable Non-invasive EEG Sensor2Cleared 510(K)
- K223738Alpha Control Liner System (ACLS)2Cleared 510(K)
- K223775EZ-STIK Electrodes2Cleared 510(K)
- K223605ControlSeal Electrode (ELSB)2Cleared 510(K)
- K222453Self-adhesive Electrode2Cleared 510(K)
- K220002Dexus Prosthetics System (Model: MSL1, MSR1)2Cleared 510(K)
- K213884Disposable EEG cable2Cleared 510(K)
- K213879Self-adhesive Electrode2Cleared 510(K)
- K210383Wrap Accessory Electrodes2Cleared 510(K)
- K211315Comby EEG Caps2Cleared 510(K)
- K212191Adhesive Electrodes2Cleared 510(K)
- K210448Adhesive Electrode2Cleared 510(K)
- K210805Ceribell Instant EEG Headband2Cleared 510(K)
- K202636Metallic Fabric Electrodes2Cleared 510(K)
- K211839Electrode Market Disposable Surface Electrodes2Cleared 510(K)
- K203158BioWave BioWraps2Cleared 510(K)
- K200942Well-Life Garment Electrodes (GM Series)2Cleared 510(K)
- K202913NeuroCap (Model DEC22)2Cleared 510(K)
- K203079MR Conditional Sticky Pad Electrode2Cleared 510(K)
- K192568Jiajian Self-Adhesive Electrode2Cleared 510(K)
- K200540BRAINSTREAM Disposable Deep Cup EEG Electrodes2Cleared 510(K)
- K190118Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)2Cleared 510(K)
- K200162Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)2Cleared 510(K)
- K192564Disposable Gold Cup EEG Electrodes2Cleared 510(K)
- K191179Myo Plus2Cleared 510(K)
- K191225EEG Electrode Template2Cleared 510(K)
- K190617Wrap accessory electrodes2Cleared 510(K)
- K190700ELECTRODES PAD2Cleared 510(K)
- K191083COMPLETE CONTROL System Gen22Cleared 510(K)
- K190416Dome Electrode2Cleared 510(K)
- K180232DAEHAN Disposable CUP Electrodes2Cleared 510(K)
- K183154SM Electrodes2Cleared 510(K)
- K182111DL Self-adhesive Electrode2Cleared 510(K)
- K182757Espire Elbow Pro, Espire Elbow Hybrid2Cleared 510(K)
- K180247DAEHAN Adhesive Surface Electrodes2Cleared 510(K)
- K182112Sense System with IBT Electrodes2Cleared 510(K)
- K181234Self-adhesive Electrode2Cleared 510(K)
- K180865ZMI Self-Adhesive Electrodes2Cleared 510(K)
- K171798Silverwear Silver Pro Garment Device2Cleared 510(K)
- K180773Reusable and Self-Adhesive Electrodes2Cleared 510(K)
- K180524EEG-Now2Cleared 510(K)
- K172866NeuroCap2Cleared 510(K)
- K172887XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV)2Cleared 510(K)
- K173571Element System with IBT Electrodes2Cleared 510(K)
- K173186S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D2Cleared 510(K)
- K171722Electrodes with snap / Electrodes with pigtail2Cleared 510(K)
- K171721Electrodes with silver conductive2Cleared 510(K)
- K171102Ives MR Conditional Cup Electrode2Cleared 510(K)
- K171381Adhesive Electrodes2Cleared 510(K)
- K172503MR Conditional Cup Electrode, MR Conditional Webb Electrode2Cleared 510(K)
- K172703Disposable Snap Electrode2Cleared 510(K)
- K171459Ceribell Instant EEG Headband2Cleared 510(K)
- K170744Adhesive Electrodes2Cleared 510(K)
- K162460WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts2Cleared 510(K)
- K162891Complete Control System2Cleared 510(K)
- K163547MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 962Cleared 510(K)
- K161282FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W2Cleared 510(K)
- K160081TENS Electrodes2Cleared 510(K)
- K160138Adhesive Electrodes2Cleared 510(K)
- K153019Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes2Cleared 510(K)
- K152815Mailuokang Self-adhesive Electrode2Cleared 510(K)
- K152648Ennova Self-adhesive Electrode2Cleared 510(K)
- K151693Dr-Ho's Foot Pad Electrode2Cleared 510(K)
- K151576Neon EEG2Cleared 510(K)
- K150971Zekang Self-adhesive Electrode2Cleared 510(K)
- K151033Philips Self-Adhesive Electrodes2Cleared 510(K)
- K142159DISPOSABLE PRE-GELLED SURFACE ELECTRODE2Cleared 510(K)
- K143506BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL (4 ELECTRODES)2Cleared 510(K)
- K142099CUTANEOUS ELECTRODES2Cleared 510(K)
- K140586ASCEND ELECTRODE2Cleared 510(K)
- K141342WEARABLE THERAPY GARMENTS2Cleared 510(K)
- K141076GARMENT ELECTRODES2Cleared 510(K)
- K131720HIVOX SELF ADHESIVE ELECTRODE GEL PADS2Cleared 510(K)
- K123795AXON-BUS PROSTHETIC SYSTEM2Cleared 510(K)
- K140340SKINTACT2Cleared 510(K)
- K132422PALS PLATINUM NEUROSTIMULATION ELECTRODES2Cleared 510(K)
- K132057DYNATRON PELTIER THERMOSTIM PROBE2Cleared 510(K)
- K132998WANDY SELF-ADHESIVE ELECTRODES2Cleared 510(K)
- K132588ADHESIVE ELECTRODES2Cleared 510(K)
- K130987VALUTRODE NEUROSTIMLATION ELECTRODES2Cleared 510(K)
- K130816INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)2Cleared 510(K)
- K130287MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE2Cleared 510(K)
- K123915DE48-PLUS2Cleared 510(K)
- K113375ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE2Cleared 510(K)
- K122376PMT TRUSCAN SURFACE ELECTRODE2Cleared 510(K)
- K121816SENSUS ELECTRODE2Cleared 510(K)
- K121483REUSABLE CUTANEOUS ELECTRODE2Cleared 510(K)
- K120835DYNATRON THERMOSTIM PROBE-DONE2Cleared 510(K)
- K120494DISPOSABLE ADHESIVE SURFACE ELECTRODE2Cleared 510(K)
- K120516LONG LIFE PADTM2Cleared 510(K)
- K112319ELECTRO-CAP SYSTEM2Cleared 510(K)
- K112312THERATRODE2Cleared 510(K)
- K112934NEUROTECH RECOVERY2Cleared 510(K)
- K111737DISPOSABLE ELECTRODE2Cleared 510(K)
- K111270REUSABLE STIMULATING ELECTRODES2Cleared 510(K)
- K110289FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE2Cleared 510(K)
- K103719LIFECARE CONDUCTIVE GARMENTS2Cleared 510(K)
- K110223WAVEGUARD (TM) EEG CAP2Cleared 510(K)
- K102614AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 402Cleared 510(K)
- K102842ADHESIVE ELECTRODES2Cleared 510(K)
- K100418SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE2Cleared 510(K)
- K092828STATNET, MODEL 31002Cleared 510(K)
- K091762DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE2Cleared 510(K)
- K092546GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM2Cleared 510(K)
- K092793MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 4112Cleared 510(K)
- K090889EMSI GARMENT ELECTRODES2Cleared 510(K)
- K093183BIS QUATRO SENSOR2Cleared 510(K)
- K083758SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS2Cleared 510(K)
- K083302LIFECARE ELECTRODES2Cleared 510(K)
- K091163PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST2Cleared 510(K)
- K091854BIS CLICK SENSOR/CABLE2Cleared 510(K)
- K083756GUARDIAN 150 ELECTRODE2Cleared 510(K)
- K090198JIAJIAN SELF-ADHESIVE ELECTRODE2Cleared 510(K)
- K090951RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDUCTIVE GARMENT , MODEL RS-FBG2Cleared 510(K)
- K083441FREEDOM STIM 100 AND 200 ELECTRODE AND LEADWIRE EXTENSION2Cleared 510(K)
- K083350TENS/NMES/FES STIMULATING ELECTRODE2Cleared 510(K)
- K082065WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP2Cleared 510(K)
- K081279PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-20002Cleared 510(K)
- K083818UNIVERSAL ELECTRODES2Cleared 510(K)
- K082540GE ENTROPY SENSOR2Cleared 510(K)
- K081871UNIVERSAL ELECTRODES2Cleared 510(K)
- K080298DERMABIOSAFE2Cleared 510(K)
- K080276SELF-ADHESIVE ELECTRODES2Cleared 510(K)
- K071446ELECTRODE ARRAY CAP2Cleared 510(K)
- K080902FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-0582Cleared 510(K)
- K080386COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE2Cleared 510(K)
- K073532DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES2Cleared 510(K)
- K072799TARGET STERILE ELECTRODE2Cleared 510(K)
- K062580GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)2Cleared 510(K)
- K072016CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE2Cleared 510(K)
- K071118GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE2Cleared 510(K)
- K070807CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTRODES2Cleared 510(K)
- K070612TOP-RANK ADHESIVE ELECTRODE2Cleared 510(K)
- K070069ZIPPREP ELECTRODE2Cleared 510(K)
- K062675GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES2Cleared 510(K)
- K062198SUNSPOTS PRE-GELLED SURFACE ELECTRODES2Cleared 510(K)
- K062692BIS BILATERAL SENSOR2Cleared 510(K)
- K063402WICK ELECTRODE, MODEL M0192602Cleared 510(K)
- K061269XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES2Cleared 510(K)
- K061343INSPIRSTAR GLOVE ELECTRODE2Cleared 510(K)
- K061148RHYTHMLINK DISC ELECTRODES2Cleared 510(K)
- K053626INTERX500 FLEXIBLE ARRAY ELECTRODE2Cleared 510(K)
- K052875PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES2Cleared 510(K)
- K053214THERAKNIT GARMENT ELECTRODE2Cleared 510(K)
- K052188CUTANEOUS ELECTRODE2Cleared 510(K)
- K051529AMBU NEUROLINE GROUND2Cleared 510(K)
- K050788EVERLIFE2Cleared 510(K)
- K050469EZ-STIK ELECTRODES2Cleared 510(K)
- K043009BRAINET KIT2Cleared 510(K)
- K041902MANTRA ELECTRODE2Cleared 510(K)
- K042301PROTENS ELECTRODE2Cleared 510(K)
- K041953VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART2Cleared 510(K)
- K041670BIS PEDIATRIC SENSOR2Cleared 510(K)
- K032278AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE2Cleared 510(K)
- K032833MYOSYSTEM WITH CUSTOMIZING2Cleared 510(K)
- K030564THERMOSKIN CONDUCTIVE PADS2Cleared 510(K)
- K030800ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES2Cleared 510(K)
- K030375SOFT-TOUCH TENS ELECTRODE2Cleared 510(K)
- K030297FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 34441302Cleared 510(K)
- K022917HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES2Cleared 510(K)
- K021537MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A100052Cleared 510(K)
- K023212AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS2Cleared 510(K)
- K020670MODEL 4310 PSARRAY2 EEG ELECTRODE2Cleared 510(K)
- K020903DOCXS B SERIES ELECTRODES2Cleared 510(K)
- K021986BRAINET2Cleared 510(K)
- K022197SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY2Cleared 510(K)
- K020735SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES2Cleared 510(K)
- K020445THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG2Cleared 510(K)
- K003896LYMPHA VISION-EXPERT2Cleared 510(K)
- K020468CHIN ELECTRODE2Cleared 510(K)
- K012463LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL2Cleared 510(K)
- K011691KIMSTIM AURICULAR ELECTRODE2Cleared 510(K)
- K013813MODIFICATION TO:APEX MEDICAL IF-41002Cleared 510(K)
- K012140COM-PATCH2Cleared 510(K)
- K010431LEAD-LOK REUSABLE TENS/ NMES ELECTRODES2Cleared 510(K)
- K011411SELF-ADHESIVE ELECTRODES2Cleared 510(K)
- K010543KM-30 TENS ELECTRODE2Cleared 510(K)
- K010638NEUROPLUS, MODEL A10040, A10041, A10042, A100432Cleared 510(K)
- K002219WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE2Cleared 510(K)
- K002227WANDY SILICONE CONDUCTIVE RUBBER PAD2Cleared 510(K)
- K001521SOFTSENS2Cleared 510(K)
- K000870KM-10 TENS ELECTRODE2Cleared 510(K)
- K001980ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-01102Cleared 510(K)
- K002734ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-01062Cleared 510(K)
- K001117COMFORT STIM2Cleared 510(K)
- K000947ULTRASTIM ELECTRODE, MODEL US40402Cleared 510(K)
- K001055MODEL 4300 PSARRAY EEG ELECTRODE SET2Cleared 510(K)
- K000865QUIK-CAP2Cleared 510(K)
- K994330ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-00762Cleared 510(K)
- K993130ULTRA-GARMENT ELECTRODE2Cleared 510(K)
- K983097TENS/FES/NMES ELECTRODES2Cleared 510(K)
- K991772CUTANEOUS (DISC) ELECTRODE2Cleared 510(K)
- K991771DIGITAL RING ELECTRDE2Cleared 510(K)
- K991770CUTANEOUS (GROUND) ELECTRODE2Cleared 510(K)
- K991769CUTANEOUS (BAR) ELECTRODE2Cleared 510(K)
- K991199BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 1502Cleared 510(K)
- K982096DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO2Cleared 510(K)
- K982053EEG ELECTRODES MODEL 445 SERIES2Cleared 510(K)
- K990370MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/NMES)2Cleared 510(K)
- K983741EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL20202Cleared 510(K)
- K980410SLE ELECTRODES AND ACCESSORIES2Cleared 510(K)
- K971914TECA NCS ELECTRODE SYSTEM 20002Cleared 510(K)
- K980229MSB TENS ELECTRODES (DISPOSABLE)2Cleared 510(K)
- K972122DREAM CATCHER2Cleared 510(K)
- K970639NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K2Cleared 510(K)
- K970426VALUETRODE2Cleared 510(K)
- K965194MEDICOM, TENS ELECTRODES2Cleared 510(K)
- K964433AQUABOND ELECTRODE2Cleared 510(K)
- K962283EEG ELECTRODES2Cleared 510(K)
- K963236M & R DISPOSABLE ELECTRODE (14200)2Cleared 510(K)
- K961821ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR2Cleared 510(K)
- K961609MODEL 1220, OR E-NET (54-62 CM)2Cleared 510(K)
- K961141EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 82202Cleared 510(K)
- K960873MODEL 1210, MEDIUM E-NET2Cleared 510(K)
- K960885MODEL 1240, SMALL E NET2Cleared 510(K)
- K960732HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 15002Cleared 510(K)
- K953354EMG DISC RECORDING ELECTRODE2Cleared 510(K)
- K953356EMG RECORDING RING ELECTRODE2Cleared 510(K)
- K953361EMG DISC RECORDING ELECTRODE2Cleared 510(K)
- K944314DISPOSABLE TM-E COCHGTRODE - BLSC PART NO. 1011232Cleared 510(K)
- K952908EMG DISC RECORDING ELECTRODE WITH PIN2Cleared 510(K)
- K952690EMG DISC RECORDING ELECTRODE WITH PIN2Cleared 510(K)
- K943449NEUROLOGICAL DIAGNOSTIC DEVICES2Cleared 510(K)
- K95321922MM STAINLESS STEEL DISC ELECTRODE, WITH PIN2Cleared 510(K)
- K95322032MM NICKEL PLATED DISC ELECTRODE2Cleared 510(K)
- K952176DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-K2Cleared 510(K)
- K944543BIOFLEX GARMENTS, ASSORTED MODELS2Cleared 510(K)
- K950782MEDI-TRAC EEG ELECTRODE2Cleared 510(K)
- K946318MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE2Cleared 510(K)
- K950491RICH-MAR CARBON ELECTRODES2Cleared 510(K)
- K944487ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES2Cleared 510(K)
- K943009SMD ELECTRODES2Cleared 510(K)
- K941986CUTANEOUS ELECTRODE2Cleared 510(K)
- K941799DISPOSABLE CUTANEOUS ELECTRODES2Cleared 510(K)
- K942921NEUROLINK EEG/EP/EMG SURFACE ELECTRODES2Cleared 510(K)
- K933808EEG CUP ELECTRODE2Cleared 510(K)
- K933805RING ELECTRODE2Cleared 510(K)
- K944603CONMED VERSA STEM NEUROMUSCULAR STIMULATION/TENS2Cleared 510(K)
- K943126ELECTROFLEX2Cleared 510(K)
- K940012SMARTBRACE ELECTRODE2Cleared 510(K)
- K941568K-10-VS, DA-05-VS, RECORDING ELECTRODES2Cleared 510(K)
- K933801ELECTRODE, CUTANEOUS2Cleared 510(K)
- K942461NEUROLOGY ACCESSORIES - MARK-EASY 10-202Cleared 510(K)
- K934580DANTEC 13R45 BAR ELECTRODE2Cleared 510(K)
- K942718CLOTH TENS/BNES ELECTRODE2Cleared 510(K)
- K933802CUTANEOUS ELECTRODE2Cleared 510(K)
- K933807GROUND PLATE ELECTRODE2Cleared 510(K)
- K933803DISPOSABLE TAB ELECTRODE2Cleared 510(K)
- K932299ELECTRO-MESH2Cleared 510(K)
- K936101CONMED VERSA-STIM NEUROMUSCULAR STIMULATION ELECTRODE2Cleared 510(K)
- K940704CONMED VERSA-STIM INTERFERENTIAL ELECTRODE2Cleared 510(K)
- K931430CUTANEOUS ELECTRODE2Cleared 510(K)
- K931426NF-11-E DISPOSABLE REFERENCE/RECORDING ELECTRODE2Cleared 510(K)
- K933814PHOTOSTRESS RECOVERY TESTER2Cleared 510(K)
- K931925TPK CUTANEOUS ELECTRODE2Cleared 510(K)
- K922393EMITENS ELECTRODES2Cleared 510(K)
- K915864MONOTRODE CUTANEOUS ELECTRODE2Cleared 510(K)
- K924473DISPOSABLE THERAPY ELECTRODE2Cleared 510(K)
- K925706REUSABLE FINGER CLIP RECORDING ELECTRODE2Cleared 510(K)
- K920674ELECTROLINK2Cleared 510(K)
- K912210PRO-CHILL STIMPACK2Cleared 510(K)
- K920264BIO-DETEK TRACERITE EEG ELECTRODE2Cleared 510(K)
- K912643ELECTRODE2Cleared 510(K)
- K913031K-STIM2Cleared 510(K)
- K915333ELECTRODE USING PROMEON RG-60 SERIES GEL2Cleared 510(K)
- K914384MEDICAL DESIGNS REUSABLE CARBON RUBBER ELECTRODE2Cleared 510(K)
- K911366PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE2Cleared 510(K)
- K913373GLOBALCARE ELECTRODE2Cleared 510(K)
- K911989GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT.2Cleared 510(K)
- K911069VERSA-STIM ELECTRODE LINE MODIFIED2Cleared 510(K)
- K9055393M 6830 ELECTRODE2Cleared 510(K)
- K903554NORTECH MODEL 87202204 ELECTRODE2Cleared 510(K)
- K903402GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L2Cleared 510(K)
- K903427NORTECH MODEL 86901000 ELECTRODE2Cleared 510(K)
- K902719SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT2Cleared 510(K)
- K901809LUMISCOPE ELECTRODES MODELS EL-08,11,15,06,21,252Cleared 510(K)
- K902195TBD TENS REUSABLE ELECTRODE2Cleared 510(K)
- K901575REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD2Cleared 510(K)
- K900825'POLYSTIM'2Cleared 510(K)
- K901102MODIFIED ISLAND PIN TENS DISPOSABLE ELECTRODE2Cleared 510(K)
- K901103MODIFIED ISLAND SNAP TENS DISPOSABLE ELECTRODE2Cleared 510(K)
- K896766TD-28 DISPOSABLE ELECTRODE2Cleared 510(K)
- K900997K-STERILE TENS ELECTRODES2Cleared 510(K)
- K900606'CONDUCTOR' DISPOSABLE TENS ELECTRODE2Cleared 510(K)
- K900656SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT.2Cleared 510(K)
- K900059BIOPOTENTIAL SURFACE ELECTRODE2Cleared 510(K)
- K896844BABE-EASE NEONATAL CLOTH ECG ELECTRODE2Cleared 510(K)
- K896936L.A.S.P. LUMBAR AND SACRAL PAD, REPOSITION. SNAP2Cleared 510(K)
- K896485MODIFIED ISLAND TENS DISP. ELECTRODE FOR SNAP CONN2Cleared 510(K)
- K893793TENZCARE ELECTRODE 68622Cleared 510(K)
- K895081PROMONTORY STIMULATING ELECTRODE2Cleared 510(K)
- K890981ELECTRO-TOUCH (ET) GLOVE2Cleared 510(K)
- K895604SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES2Cleared 510(K)
- K894043SPECT.E.N.S REPOSITIONABLE, SNAP-TYPE, TENS2Cleared 510(K)
- K894042SPECT.E.N.S. REPOSITIONABLE, PIN TYPE, TENS2Cleared 510(K)
- K891107INDICATENS INDICATOR ELECTRODE MODEL 22Cleared 510(K)
- K891105INDICATENS MODEL 4X4 SP ELECTRODE STIM. PATCHES2Cleared 510(K)
- K890747EMPI REUSEABLE PIN-STYLE TENS ELECTRODE2Cleared 510(K)
- K890614EMPI MULTIDAY TENS DISPOSABLE ELECTRODE2Cleared 510(K)
- K890605EMPI ISLAND TENS ELECTRODE2Cleared 510(K)
- K890710DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS2Cleared 510(K)
- K884814BIOTENS2Cleared 510(K)
- K884348MODIFIED JELTRODE(TM) ELECTRODES DEEMED2Cleared 510(K)
- K882464DTL MICROTOUCH EYE ELECTRODE2Cleared 510(K)
- K882888MULTIDAY, MODELS 8300 AND 83102Cleared 510(K)
- K882886PROGEL (TM) DUAL ELECTRODE PAD, MODEL 85352Cleared 510(K)
- K882887PROGEL(TM), MODELS 8630 AND 86352Cleared 510(K)
- K882809THYMAPAD2Cleared 510(K)
- K881749STRAIGHT-LINE FINISH FOR IMPLANTABLE PULSE GENERA.2Cleared 510(K)
- K881872TENS ELECTRODE MODEL 238P2Cleared 510(K)
- K881871SPARE MS 700 TENS ELECTRODE2Cleared 510(K)
- K881444T.E.N.S. ELECTRODE NON-STERILE2Cleared 510(K)
- K880545STIMWEAR GARMENTS, SIGNAL I AND SIGNAL II2Cleared 510(K)
- K881343DURADERM BUTTERFLY2Cleared 510(K)
- K880649TENS ELECTRODE SNAP TYPE, DISPOSA., SELF-ADHERING2Cleared 510(K)
- K875284MEDTRONIC SNAP EASE MODEL 7795 CUTANEOUS ELECTRODE2Cleared 510(K)
- K874469TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)2Cleared 510(K)
- K874735DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE2Cleared 510(K)
- K873298ELEC-TIP2Cleared 510(K)
- K874075PT-100-30 SOMATOSENSORY STIMULATING ELECTRODE2Cleared 510(K)
- K872976TENS PALS PLUS2Cleared 510(K)
- K872250LECTEC STIMULATING ELECTRODE2Cleared 510(K)
- K872574TENSAGAIN2Cleared 510(K)
- K872492ALTERNATE SUPPLIERS FOR TENS ELECTRODE2Cleared 510(K)
- K872044CARBON ELECTRODE2Cleared 510(K)
- K871292HEALTH CONCEPTS CONDUCTIVE MEMBRANE2Cleared 510(K)
- K871222TANTONE MULTI-DAY #633 TENS ELECTRODE2Cleared 510(K)
- K871026DISPOSABLE, PIN-CONN. POLYMER-GEL ELECT. FOR TENS2Cleared 510(K)
- K870160DYNEX DISPOSABLE SELF-ADHERING ELECTRODE W/TENS2Cleared 510(K)
- K864973TENZCARE(TM) SNAP ELECTRODE 68672Cleared 510(K)
- K864032EM TENS WINDOW ELECTRODES2Cleared 510(K)
- K862377QMED SELF ADHERING ELECTRODE2Cleared 510(K)
- K863307TENZCARE SNAP ELECTRODE, NO. 68652Cleared 510(K)
- K863035POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER2Cleared 510(K)
- K862718VERSA STIM2Cleared 510(K)
- K862231EMPI, MODEL 1000 HAND HELD ELECTRODE2Cleared 510(K)
- K862028ULTRAHESIVE II POSTOP ELECTRODE2Cleared 510(K)
- K862011MULTI-DAY ELECTRODES2Cleared 510(K)
- K861956JELTRODE2Cleared 510(K)
- K854204DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENS2Cleared 510(K)
- K854513EMPI, NMS/SUE CUTANEOUS ELECTRODE2Cleared 510(K)
- K853633TENS CONDUCTIVE MEDIA PAD2Cleared 510(K)
- K853552SENTRY FLEXIBLE TENS2Cleared 510(K)
- K850646ECLIPSE SELF ADHERING ELECTRODE2Cleared 510(K)
- K852298TENS-AID STERILE ELECTRODES FOR POST-OP TENS2Cleared 510(K)
- K852267ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES2Cleared 510(K)
- K851175TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE2Cleared 510(K)
- K851303COMFORT-EASE ELECTRODE2Cleared 510(K)
- K850108EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG2Cleared 510(K)
- K850311DISPOS. CONDUCTIVE ADHESIVE TENS PAD2Cleared 510(K)
- K850131CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS2Cleared 510(K)
- K843964TENS-AID PREMIUM ELECTRODES2Cleared 510(K)
- K844098CANMED 1032Cleared 510(K)
- K844023AQUAFORM ELECTRODES WITH AQUAPORE2Cleared 510(K)
- K844646SIEGEN SURFACE ELECTRODES2Cleared 510(K)
- K844097CANMED 103 9300 ELECTRODE2Cleared 510(K)
- K842033ELECTRODE PLACEMENT ARM PART GARMENT2Cleared 510(K)
- K842271ELECTRODE, SURFACE EEG ELECTRODE2Cleared 510(K)
- K841877EEG ELECTRODE PAD2Cleared 510(K)
- K841685EEG ELECTRODES2Cleared 510(K)
- K840395ELECTRO-MESH GLOVE2Cleared 510(K)
- K840396ELECTRO-MESH WRAP2Cleared 510(K)
- K840592ELECTRODE PLACEMENT LUMBAR SHORTS2Cleared 510(K)
- K840591ELECTRODE PLACEMENT SLEEVE2Cleared 510(K)
- K832295S2MEDIAN2Cleared 510(K)
- K832296S2 POSTERIOR-TIB2Cleared 510(K)
- K832145MONOBLOCK PROSTOPERATIVE TENS ELECTRODE2Cleared 510(K)
- K831785NEURO EASE2Cleared 510(K)
- K831104TENZCARE MUSCLE STIMULATION ELECTRODES2Cleared 510(K)
- K831046ELECTRODE 37992Cleared 510(K)
- K830798STERILE SURGICAL PAIN RELIEF ELECTRODE2Cleared 510(K)
- K830597BABY CAP, ELECTRODE SET & BOARD ADAPTOR2Cleared 510(K)
- K830602PRECISION CAP STRAPS2Cleared 510(K)
- K830601FOAMIES DIAPOS. FOAM RUBBER PADS2Cleared 510(K)
- K830600REFERENCE & MONITORING ELECTRODE2Cleared 510(K)
- K830599LOCALIZING ELECTRODE2Cleared 510(K)
- K830598EVOKED POTENTIAL CAP W/EVOKED POTENTIAL2Cleared 510(K)
- K830521PRECISION EEG CAP W/ELECTRODE SET AND2Cleared 510(K)
- K822378TENS ELECTRODE2Cleared 510(K)
- K822224EMPI SINGLE USE2Cleared 510(K)
- K820876MODEL 3854 ELECTRODE2Cleared 510(K)
- K820082POST-OP ELECTRODE (TENS ELECTRODE)2Cleared 510(K)
- K812418MEDTRONIC #3798 ELECTRODE2Cleared 510(K)
- K812299ELECTRO-SNAP2Cleared 510(K)
- K810206DUAL TYPE ELECTRODE2Cleared 510(K)
- K810262AUTOMATIC ELECTRODE PLACEMENT BELT2Cleared 510(K)
- K803012SHUR-PATCH TAPE PATCH2Cleared 510(K)
- K800117TRU-PULSE PADS2Cleared 510(K)
- K792351MEDTRONIC MOD. 3852 STERIL-ICE ELECTRODE2Cleared 510(K)
- K791097CEPTORTRODE WITH CEPTOR HESIVE2Cleared 510(K)
- K790850T.E.N.S.* SINGLE-USE ELECTRODE2Cleared 510(K)
- K790542ELECTRODES, STAODERM STERILE2Cleared 510(K)
- K790316ELECTRODE, ELECTROFLEX2Cleared 510(K)
- K790345STIMTECH TENS ELECTRODE2Cleared 510(K)
- K790269CEPTOR HESIVE2Cleared 510(K)
- K782137MEDTRONIC MODEL 3797 ELECTRODE2Cleared 510(K)
- K781494EEG LEAD ASSEMBLY2Cleared 510(K)
- K781314THERAPY UNIT & ELECTRODIAG.2Cleared 510(K)
- K780537EAR ELECTRODE-ADULT & PEDIATRIC2Cleared 510(K)
- K780045ELECTRODE CAP2Cleared 510(K)
- K771719KARAYA ELECTRODES2Cleared 510(K)
- K770447EPC INSTICKS2Cleared 510(K)
- K770448INS - T.E.N.S.2Cleared 510(K)
- K770323VERI/TRODES2Cleared 510(K)
- K760947PREGELLED DISPOSABLE ELECTRODE2Cleared 510(K)
- K760312ELECTRODE, PNS2Cleared 510(K)
- GXZElectrode, Needle2Product Code
- GYATester, Electrode/Lead, Electroencephalograph1Product Code
- GXSMonitor, Alpha2Product Code
- GWEStimulator, Photic, Evoked Response2Product Code
- GWFStimulator, Electrical, Evoked Response2Product Code
- GWGEndoscope, Neurological2Product Code
- GWIDiscriminator, Two-Point1Product Code
- GWJStimulator, Auditory, Evoked Response2Product Code
- GWKConditioner, Signal, Physiological2Product Code
- GWLAmplifier, Physiological Signal2Product Code
- GWMDevice, Monitoring, Intracranial Pressure2Product Code
- GWNNystagmograph2Product Code
- GWQFull-Montage Standard Electroencephalograph2Product Code
- GWRGenerator, Electroencephalograph Test Signal1Product Code
- GWSAnalyzer, Spectrum, Electroencephalogram Signal1Product Code
- GWWAtaxiagraph1Product Code
- GWXFork, Tuning1Product Code
- GWYPinwheel1Product Code
- GWZPercussor1Product Code
- GXBEsthesiometer1Product Code
- GYBMedia, Electroconductive2Product Code
- GYCElectrode, Cortical2Product Code
- GYDTransducer, Tremor2Product Code
- GYEEncephalogram Telemetry System2Product Code
- GZKElectrode, Nasopharyngeal2Product Code
- GZLElectrode, Depth2Product Code
- GZMAnalyzer, Rigidity2Product Code
- GZNRheoencephalograph3Product Code
- GZODevice, Galvanic Skin Response Measurement2Product Code
- GZPStimulator, Mechanical, Evoked Response2Product Code
- HCJDevice, Skin Potential Measurement2Product Code
- HCSDevice, Temperature Measurement, Direct Contact, Powered2Product Code
- JXEDevice, Nerve Conduction Velocity Measurement2Product Code
- JXFPlethysmograph, Ocular3Product Code
- LLNDevice, Vibration Threshold Measurement1Product Code
- LQWTest, Temperature Discrimination1Product Code
- NCGNeuropsychiatric Interpretative Electroencephalograph Assessment Aid2Product Code
- NTUEvoked Potential Stimulator, Thermal2Product Code
- OLTNon-Normalizing Quantitative Electroencephalograph Software2Product Code
- OLUNormalizing Quantitative Electroencephalograph Software2Product Code
- OLVStandard Polysomnograph With Electroencephalograph2Product Code
- OLWIndex-Generating Electroencephalograph Software2Product Code
- OLXSource Localization Software For Electroencephalograph Or Magnetoencephalograph2Product Code
- OLYMagnetoencephalograph2Product Code
- OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph2Product Code
- OMAAmplitude-Integrated Electroencephalograph2Product Code
- OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph2Product Code
- OMCReduced- Montage Standard Electroencephalograph2Product Code
- ORTBurst Suppression Detection Software For Electroencephalograph2Product Code
- PIWBrain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid2Product Code
- PKQComputerized Cognitive Assessment Aid2Product Code
- PNAEvoked Photon Image Capture Device1Product Code
- POMComputerized Cognitive Assessment Aid For Concussion2Product Code
- POPCranial Motion Measurement Device2Product Code
- POSPhysiological Signal Based Seizure Monitoring System2Product Code
- PSPIntracranial Pressure & Temperature Monitoring Kit2Product Code
- PTBAtaxiagraph With Interpretive Software1Product Code
- PTYComputerized Cognitive Assessment Aid, Exempt2Product Code
- PVPNeurological Test Kit1Product Code
- QEABrain Injury Adjunctive Interpretive Oculomotor Assessment Aid2Product Code
- QPFPediatric Autism Spectrum Disorder Diagnosis Aid2Product Code
- OPTInfrared Hematoma Detector2Product Code
- 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
- 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
Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K232995
- 510(k) Type
- Traditional
- Applicant
- Shenzhen Roundwhale Technology Co., Ltd.
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/11/2024
- Days to Decision
- 111 days
- Submission Type
- Summary