Product Code: GXY FDA class 2 21 CFR 882.1320

Electrode, Cutaneous

Neurology

The Cutaneous Electrode is a surface electrode placed on the skin for use in neurological monitoring procedures such as electroencephalography (EEG), nerve conduction studies, or evoked potential testing. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is GXY under regulation 21 CFR 882.1320 in the Neurology specialty. It is eligible for third-party 510(k) review.

510(k)s
427
FEI Numbers
242
Registration Numbers
242
Unique Applicants
257
Years Active
49

Basic Information

Product Code
GXY
Device Class
FDA class 2
Regulation Number
882.1320
Medical Specialty
Neurology
Review Panel
NE
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 427 510(k) clearances via K numbers.

K Number Device Name
K243788 IceCap product line
K243243 Delphi MCS Electrode Cap
K241512 Electrode Pad
K242326 Wave Electrode (AE02-60); Wave Electrode (AE02-50)
K241160 CAIs Sensor (CAIs-001)
K240575 WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)
K242346 Grass® MR Conditional/CT Cup Electrodes
K240108 Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01)
K240884 Glide (91000-GL-X)
K240668 Amydi-med Disposable Non-invasive EEG electrodes
K232995 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
K221199 Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)
K231167 Conductive Silicone Rubber Electrode
K231164 Conductive carbon film electrode
K232052 Ceribell Instant EEG Headband
K221589 Starly pad
K230533 Motive™ Electrode
K223086 Ceribell Instant EEG Headcap
K222671 DeltaScan Patch
K222863 Garment Electrodes
K222252 Self-adhesive Electrode
K220448 Disposable Non-invasive EEG Sensor
K223738 Alpha Control Liner System (ACLS)
K223775 EZ-STIK Electrodes
K223605 ControlSeal Electrode (ELSB)
K222453 Self-adhesive Electrode
K220002 Dexus Prosthetics System (Model: MSL1, MSR1)
K213884 Disposable EEG cable
K213879 Self-adhesive Electrode
K210383 Wrap Accessory Electrodes
K211315 Comby EEG Caps
K212191 Adhesive Electrodes
K210448 Adhesive Electrode
K210805 Ceribell Instant EEG Headband
K202636 Metallic Fabric Electrodes
K211839 Electrode Market Disposable Surface Electrodes
K203158 BioWave BioWraps
K200942 Well-Life Garment Electrodes (GM Series)
K202913 NeuroCap (Model DEC22)
K203079 MR Conditional Sticky Pad Electrode
K192568 Jiajian Self-Adhesive Electrode
K200540 BRAINSTREAM Disposable Deep Cup EEG Electrodes
K190118 Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)
K200162 Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)
K192564 Disposable Gold Cup EEG Electrodes
K191179 Myo Plus
K191225 EEG Electrode Template
K190617 Wrap accessory electrodes
K190700 ELECTRODES PAD
K191083 COMPLETE CONTROL System Gen2
K190416 Dome Electrode
K180232 DAEHAN Disposable CUP Electrodes
K183154 SM Electrodes
K182111 DL Self-adhesive Electrode
K182757 Espire Elbow Pro, Espire Elbow Hybrid
K180247 DAEHAN Adhesive Surface Electrodes
K182112 Sense System with IBT Electrodes
K181234 Self-adhesive Electrode
K180865 ZMI Self-Adhesive Electrodes
K171798 Silverwear Silver Pro Garment Device
K180773 Reusable and Self-Adhesive Electrodes
K180524 EEG-Now
K172866 NeuroCap
K172887 XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV)
K173571 Element System with IBT Electrodes
K173186 S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D
K171722 Electrodes with snap / Electrodes with pigtail
K171721 Electrodes with silver conductive
K171102 Ives MR Conditional Cup Electrode
K171381 Adhesive Electrodes
K172503 MR Conditional Cup Electrode, MR Conditional Webb Electrode
K172703 Disposable Snap Electrode
K171459 Ceribell Instant EEG Headband
K170744 Adhesive Electrodes
K162460 WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts
K162891 Complete Control System
K163547 MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96
K161282 FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W
K160081 TENS Electrodes
K160138 Adhesive Electrodes
K153019 Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes
K152815 Mailuokang Self-adhesive Electrode
K152648 Ennova Self-adhesive Electrode
K151693 Dr-Ho's Foot Pad Electrode
K151576 Neon EEG
K150971 Zekang Self-adhesive Electrode
K151033 Philips Self-Adhesive Electrodes
K142159 DISPOSABLE PRE-GELLED SURFACE ELECTRODE
K143506 BIS 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)
K142099 CUTANEOUS ELECTRODES
K140586 ASCEND ELECTRODE
K141342 WEARABLE THERAPY GARMENTS
K141076 GARMENT ELECTRODES
K131720 HIVOX SELF ADHESIVE ELECTRODE GEL PADS
K123795 AXON-BUS PROSTHETIC SYSTEM
K140340 SKINTACT
K132422 PALS PLATINUM NEUROSTIMULATION ELECTRODES
K132057 DYNATRON PELTIER THERMOSTIM PROBE
K132998 WANDY SELF-ADHESIVE ELECTRODES
K132588 ADHESIVE ELECTRODES
K130987 VALUTRODE NEUROSTIMLATION ELECTRODES
K130816 INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)
K130287 MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE
K123915 DE48-PLUS
K113375 ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE
K122376 PMT TRUSCAN SURFACE ELECTRODE
K121816 SENSUS ELECTRODE
K121483 REUSABLE CUTANEOUS ELECTRODE
K120835 DYNATRON THERMOSTIM PROBE-DONE
K120494 DISPOSABLE ADHESIVE SURFACE ELECTRODE
K120516 LONG LIFE PADTM
K112319 ELECTRO-CAP SYSTEM
K112312 THERATRODE
K112934 NEUROTECH RECOVERY
K111737 DISPOSABLE ELECTRODE
K111270 REUSABLE STIMULATING ELECTRODES
K110289 FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE
K103719 LIFECARE CONDUCTIVE GARMENTS
K110223 WAVEGUARD (TM) EEG CAP
K102614 AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40
K102842 ADHESIVE ELECTRODES
K100418 SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE
K092828 STATNET, MODEL 3100
K091762 DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE
K092546 GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM
K092793 MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411
K090889 EMSI GARMENT ELECTRODES
K093183 BIS QUATRO SENSOR
K083758 SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS
K083302 LIFECARE ELECTRODES
K091163 PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST
K091854 BIS CLICK SENSOR/CABLE
K083756 GUARDIAN 150 ELECTRODE
K090198 JIAJIAN SELF-ADHESIVE ELECTRODE
K090951 RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDUCTIVE GARMENT , MODEL RS-FBG
K083441 FREEDOM STIM 100 AND 200 ELECTRODE AND LEADWIRE EXTENSION
K083350 TENS/NMES/FES STIMULATING ELECTRODE
K082065 WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP
K081279 PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000
K083818 UNIVERSAL ELECTRODES
K082540 GE ENTROPY SENSOR
K081871 UNIVERSAL ELECTRODES
K080298 DERMABIOSAFE
K080276 SELF-ADHESIVE ELECTRODES
K071446 ELECTRODE ARRAY CAP
K080902 FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058
K080386 COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE
K073532 DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES
K072799 TARGET STERILE ELECTRODE
K062580 GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)
K072016 CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE
K071118 GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE
K070807 CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTRODES
K070612 TOP-RANK ADHESIVE ELECTRODE
K070069 ZIPPREP ELECTRODE
K062675 GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES
K062198 SUNSPOTS PRE-GELLED SURFACE ELECTRODES
K062692 BIS BILATERAL SENSOR
K063402 WICK ELECTRODE, MODEL M019260
K061269 XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES
K061343 INSPIRSTAR GLOVE ELECTRODE
K061148 RHYTHMLINK DISC ELECTRODES
K053626 INTERX500 FLEXIBLE ARRAY ELECTRODE
K052875 PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES
K053214 THERAKNIT GARMENT ELECTRODE
K052188 CUTANEOUS ELECTRODE
K051529 AMBU NEUROLINE GROUND
K050788 EVERLIFE
K050469 EZ-STIK ELECTRODES
K043009 BRAINET KIT
K041902 MANTRA ELECTRODE
K042301 PROTENS ELECTRODE
K041953 VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART
K041670 BIS PEDIATRIC SENSOR
K032278 AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE
K032833 MYOSYSTEM WITH CUSTOMIZING
K030564 THERMOSKIN CONDUCTIVE PADS
K030800 ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES
K030375 SOFT-TOUCH TENS ELECTRODE
K030297 FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130
K022917 HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES
K021537 MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005
K023212 AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS
K020670 MODEL 4310 PSARRAY2 EEG ELECTRODE
K020903 DOCXS B SERIES ELECTRODES
K021986 BRAINET
K022197 SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY
K020735 SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES
K020445 THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG
K003896 LYMPHA VISION-EXPERT
K020468 CHIN ELECTRODE
K012463 LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL
K011691 KIMSTIM AURICULAR ELECTRODE
K013813 MODIFICATION TO:APEX MEDICAL IF-4100
K012140 COM-PATCH
K010431 LEAD-LOK REUSABLE TENS/ NMES ELECTRODES
K011411 SELF-ADHESIVE ELECTRODES
K010543 KM-30 TENS ELECTRODE
K010638 NEUROPLUS, MODEL A10040, A10041, A10042, A10043
K002227 WANDY SILICONE CONDUCTIVE RUBBER PAD
K002219 WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE
K001521 SOFTSENS
K000870 KM-10 TENS ELECTRODE
K001980 ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110
K002734 ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106
K001117 COMFORT STIM
K000947 ULTRASTIM ELECTRODE, MODEL US4040
K001055 MODEL 4300 PSARRAY EEG ELECTRODE SET
K000865 QUIK-CAP
K994330 ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076
K993130 ULTRA-GARMENT ELECTRODE
K983097 TENS/FES/NMES ELECTRODES
K991772 CUTANEOUS (DISC) ELECTRODE
K991771 DIGITAL RING ELECTRDE
K991770 CUTANEOUS (GROUND) ELECTRODE
K991769 CUTANEOUS (BAR) ELECTRODE
K991199 BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150
K982096 DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO
K982053 EEG ELECTRODES MODEL 445 SERIES
K990370 MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/NMES)
K983741 EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020
K980410 SLE ELECTRODES AND ACCESSORIES
K971914 TECA NCS ELECTRODE SYSTEM 2000
K980229 MSB TENS ELECTRODES (DISPOSABLE)
K972122 DREAM CATCHER
K970639 NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K
K970426 VALUETRODE
K965194 MEDICOM, TENS ELECTRODES
K964433 AQUABOND ELECTRODE
K962283 EEG ELECTRODES
K963236 M & R DISPOSABLE ELECTRODE (14200)
K961821 ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR
K961609 MODEL 1220, OR E-NET (54-62 CM)
K961141 EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220
K960885 MODEL 1240, SMALL E NET
K960873 MODEL 1210, MEDIUM E-NET
K960732 HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500
K953361 EMG DISC RECORDING ELECTRODE
K953356 EMG RECORDING RING ELECTRODE
K953354 EMG DISC RECORDING ELECTRODE
K944314 DISPOSABLE TM-E COCHGTRODE - BLSC PART NO. 101123
K952908 EMG DISC RECORDING ELECTRODE WITH PIN
K952690 EMG DISC RECORDING ELECTRODE WITH PIN
K943449 NEUROLOGICAL DIAGNOSTIC DEVICES
K953220 32MM NICKEL PLATED DISC ELECTRODE
K953219 22MM STAINLESS STEEL DISC ELECTRODE, WITH PIN
K952176 DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-K
K944543 BIOFLEX GARMENTS, ASSORTED MODELS
K950782 MEDI-TRAC EEG ELECTRODE
K946318 MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE
K950491 RICH-MAR CARBON ELECTRODES
K944487 ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES
K943009 SMD ELECTRODES
K941986 CUTANEOUS ELECTRODE
K941799 DISPOSABLE CUTANEOUS ELECTRODES
K942921 NEUROLINK EEG/EP/EMG SURFACE ELECTRODES
K933808 EEG CUP ELECTRODE
K933805 RING ELECTRODE
K944603 CONMED VERSA STEM NEUROMUSCULAR STIMULATION/TENS
K943126 ELECTROFLEX
K940012 SMARTBRACE ELECTRODE
K941568 K-10-VS, DA-05-VS, RECORDING ELECTRODES
K933801 ELECTRODE, CUTANEOUS
K942461 NEUROLOGY ACCESSORIES - MARK-EASY 10-20
K934580 DANTEC 13R45 BAR ELECTRODE
K942718 CLOTH TENS/BNES ELECTRODE
K933802 CUTANEOUS ELECTRODE
K933807 GROUND PLATE ELECTRODE
K933803 DISPOSABLE TAB ELECTRODE
K932299 ELECTRO-MESH
K936101 CONMED VERSA-STIM NEUROMUSCULAR STIMULATION ELECTRODE
K940704 CONMED VERSA-STIM INTERFERENTIAL ELECTRODE
K931430 CUTANEOUS ELECTRODE
K931426 NF-11-E DISPOSABLE REFERENCE/RECORDING ELECTRODE
K933814 PHOTOSTRESS RECOVERY TESTER
K931925 TPK CUTANEOUS ELECTRODE
K922393 EMITENS ELECTRODES
K915864 MONOTRODE CUTANEOUS ELECTRODE
K924473 DISPOSABLE THERAPY ELECTRODE
K925706 REUSABLE FINGER CLIP RECORDING ELECTRODE
K920674 ELECTROLINK
K912210 PRO-CHILL STIMPACK
K920264 BIO-DETEK TRACERITE EEG ELECTRODE
K912643 ELECTRODE
K913031 K-STIM
K915333 ELECTRODE USING PROMEON RG-60 SERIES GEL
K914384 MEDICAL DESIGNS REUSABLE CARBON RUBBER ELECTRODE
K911366 PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE
K913373 GLOBALCARE ELECTRODE
K911989 GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT.
K911069 VERSA-STIM ELECTRODE LINE MODIFIED
K905539 3M 6830 ELECTRODE
K903554 NORTECH MODEL 87202204 ELECTRODE
K903402 GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L
K903427 NORTECH MODEL 86901000 ELECTRODE
K902719 SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT
K901809 LUMISCOPE ELECTRODES MODELS EL-08,11,15,06,21,25
K902195 TBD TENS REUSABLE ELECTRODE
K901575 REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD
K900825 'POLYSTIM'
K901103 MODIFIED ISLAND SNAP TENS DISPOSABLE ELECTRODE
K901102 MODIFIED ISLAND PIN TENS DISPOSABLE ELECTRODE
K896766 TD-28 DISPOSABLE ELECTRODE
K900997 K-STERILE TENS ELECTRODES
K900606 'CONDUCTOR' DISPOSABLE TENS ELECTRODE
K900656 SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT.
K900059 BIOPOTENTIAL SURFACE ELECTRODE
K896844 BABE-EASE NEONATAL CLOTH ECG ELECTRODE
K896936 L.A.S.P. LUMBAR AND SACRAL PAD, REPOSITION. SNAP
K896485 MODIFIED ISLAND TENS DISP. ELECTRODE FOR SNAP CONN
K893793 TENZCARE ELECTRODE 6862
K895081 PROMONTORY STIMULATING ELECTRODE
K890981 ELECTRO-TOUCH (ET) GLOVE
K895604 SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES
K894043 SPECT.E.N.S REPOSITIONABLE, SNAP-TYPE, TENS
K894042 SPECT.E.N.S. REPOSITIONABLE, PIN TYPE, TENS
K891107 INDICATENS INDICATOR ELECTRODE MODEL 2
K891105 INDICATENS MODEL 4X4 SP ELECTRODE STIM. PATCHES
K890747 EMPI REUSEABLE PIN-STYLE TENS ELECTRODE
K890614 EMPI MULTIDAY TENS DISPOSABLE ELECTRODE
K890605 EMPI ISLAND TENS ELECTRODE
K890710 DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS
K884814 BIOTENS
K884348 MODIFIED JELTRODE(TM) ELECTRODES DEEMED
K882464 DTL MICROTOUCH EYE ELECTRODE
K882888 MULTIDAY, MODELS 8300 AND 8310
K882887 PROGEL(TM), MODELS 8630 AND 8635
K882886 PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535
K882809 THYMAPAD
K881749 STRAIGHT-LINE FINISH FOR IMPLANTABLE PULSE GENERA.
K881872 TENS ELECTRODE MODEL 238P
K881871 SPARE MS 700 TENS ELECTRODE
K881444 T.E.N.S. ELECTRODE NON-STERILE
K880545 STIMWEAR GARMENTS, SIGNAL I AND SIGNAL II
K881343 DURADERM BUTTERFLY
K880649 TENS ELECTRODE SNAP TYPE, DISPOSA., SELF-ADHERING
K875284 MEDTRONIC SNAP EASE MODEL 7795 CUTANEOUS ELECTRODE
K874469 TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)
K874735 DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE
K873298 ELEC-TIP
K874075 PT-100-30 SOMATOSENSORY STIMULATING ELECTRODE
K872976 TENS PALS PLUS
K872250 LECTEC STIMULATING ELECTRODE
K872574 TENSAGAIN
K872492 ALTERNATE SUPPLIERS FOR TENS ELECTRODE
K872044 CARBON ELECTRODE
K871292 HEALTH CONCEPTS CONDUCTIVE MEMBRANE
K871222 TANTONE MULTI-DAY #633 TENS ELECTRODE
K871026 DISPOSABLE, PIN-CONN. POLYMER-GEL ELECT. FOR TENS
K870160 DYNEX DISPOSABLE SELF-ADHERING ELECTRODE W/TENS
K864973 TENZCARE(TM) SNAP ELECTRODE 6867
K864032 EM TENS WINDOW ELECTRODES
K862377 QMED SELF ADHERING ELECTRODE
K863307 TENZCARE SNAP ELECTRODE, NO. 6865
K863035 POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER
K862718 VERSA STIM
K862231 EMPI, MODEL 1000 HAND HELD ELECTRODE
K862028 ULTRAHESIVE II POSTOP ELECTRODE
K862011 MULTI-DAY ELECTRODES
K861956 JELTRODE
K854204 DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENS
K854513 EMPI, NMS/SUE CUTANEOUS ELECTRODE
K853633 TENS CONDUCTIVE MEDIA PAD
K853552 SENTRY FLEXIBLE TENS
K850646 ECLIPSE SELF ADHERING ELECTRODE
K852298 TENS-AID STERILE ELECTRODES FOR POST-OP TENS
K852267 ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES
K851175 TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE
K851303 COMFORT-EASE ELECTRODE
K850108 EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG
K850311 DISPOS. CONDUCTIVE ADHESIVE TENS PAD
K850131 CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS
K843964 TENS-AID PREMIUM ELECTRODES
K844098 CANMED 103
K844023 AQUAFORM ELECTRODES WITH AQUAPORE
K844646 SIEGEN SURFACE ELECTRODES
K844097 CANMED 103 9300 ELECTRODE
K842033 ELECTRODE PLACEMENT ARM PART GARMENT
K842271 ELECTRODE, SURFACE EEG ELECTRODE
K841877 EEG ELECTRODE PAD
K841685 EEG ELECTRODES
K840396 ELECTRO-MESH WRAP
K840395 ELECTRO-MESH GLOVE
K840592 ELECTRODE PLACEMENT LUMBAR SHORTS
K840591 ELECTRODE PLACEMENT SLEEVE
K832296 S2 POSTERIOR-TIB
K832295 S2MEDIAN
K832145 MONOBLOCK PROSTOPERATIVE TENS ELECTRODE
K831785 NEURO EASE
K831104 TENZCARE MUSCLE STIMULATION ELECTRODES
K831046 ELECTRODE 3799
K830798 STERILE SURGICAL PAIN RELIEF ELECTRODE
K830602 PRECISION CAP STRAPS
K830601 FOAMIES DIAPOS. FOAM RUBBER PADS
K830600 REFERENCE & MONITORING ELECTRODE
K830599 LOCALIZING ELECTRODE
K830598 EVOKED POTENTIAL CAP W/EVOKED POTENTIAL
K830597 BABY CAP, ELECTRODE SET & BOARD ADAPTOR
K830521 PRECISION EEG CAP W/ELECTRODE SET AND
K822378 TENS ELECTRODE
K822224 EMPI SINGLE USE
K820876 MODEL 3854 ELECTRODE
K820082 POST-OP ELECTRODE (TENS ELECTRODE)
K812418 MEDTRONIC #3798 ELECTRODE
K812299 ELECTRO-SNAP
K810206 DUAL TYPE ELECTRODE
K810262 AUTOMATIC ELECTRODE PLACEMENT BELT
K803012 SHUR-PATCH TAPE PATCH
K800117 TRU-PULSE PADS
K792351 MEDTRONIC MOD. 3852 STERIL-ICE ELECTRODE
K791097 CEPTORTRODE WITH CEPTOR HESIVE
K790850 T.E.N.S.* SINGLE-USE ELECTRODE
K790542 ELECTRODES, STAODERM STERILE
K790316 ELECTRODE, ELECTROFLEX
K790345 STIMTECH TENS ELECTRODE
K790269 CEPTOR HESIVE
K782137 MEDTRONIC MODEL 3797 ELECTRODE
K781494 EEG LEAD ASSEMBLY
K781314 THERAPY UNIT & ELECTRODIAG.
K780537 EAR ELECTRODE-ADULT & PEDIATRIC
K780045 ELECTRODE CAP
K771719 KARAYA ELECTRODES
K770448 INS - T.E.N.S.
K770447 EPC INSTICKS
K770323 VERI/TRODES
K760947 PREGELLED DISPOSABLE ELECTRODE
K760312 ELECTRODE, PNS

FEI Numbers

This FDA classification entry is associated with 242 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 242 registration numbers. Click on an entry to view related FDA registrations.