FDA Product Code
FDA Product Code GXY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1320
510(k) Clearances — 440 records · page 3 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K020735 | SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES | Cathay International, Ltd. | 2002-07-12 | Traditional | PDF ↗ |
| K020445 | THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG | The Electrode Store, Inc. | 2002-05-10 | Traditional | PDF ↗ |
| K003896 | LYMPHA VISION-EXPERT | Bexley Trading, Inc. | 2002-04-24 | Abbreviated | PDF ↗ |
| K020468 | CHIN ELECTRODE | Dymedix, Inc. | 2002-04-16 | Abbreviated | PDF ↗ |
| 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 | Everyway Medical Instruments Co.,Ltd | 2002-02-05 | Traditional | PDF ↗ |
| K011691 | KIMSTIM AURICULAR ELECTRODE | Kim Institute For Rehabilitation Medicine, P.C. | 2001-12-27 | Traditional | PDF ↗ |
| K013813 | MODIFICATION TO:APEX MEDICAL IF-4100 | Apex Medical Corp. | 2001-12-14 | Special | PDF ↗ |
| K012140 | COM-PATCH | Apex Medical Corp. | 2001-10-05 | Traditional | PDF ↗ |
| K010431 | LEAD-LOK REUSABLE TENS/ NMES ELECTRODES | Lead-Lok, Inc. | 2001-09-06 | Traditional | PDF ↗ |
| K011411 | SELF-ADHESIVE ELECTRODES | Pain Management Technologies | 2001-06-13 | Traditional | PDF ↗ |
| K010543 | KM-30 TENS ELECTRODE | Katecho, Inc. | 2001-05-23 | Traditional | PDF ↗ |
| K010638 | NEUROPLUS, MODEL A10040, A10041, A10042, A10043 | Vermont Medical, Inc. | 2001-05-03 | Traditional | PDF ↗ |
| K002227 | WANDY SILICONE CONDUCTIVE RUBBER PAD | Wandy Rubber Industrial Co., Ltd. | 2001-02-02 | Traditional | PDF ↗ |
| K002219 | WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE | Wandy Rubber Industrial Co., Ltd. | 2001-02-02 | Traditional | PDF ↗ |
| K001521 | SOFTSENS | Integrated Biosensing Technologies | 2000-11-27 | Traditional | PDF ↗ |
| K000870 | KM-10 TENS ELECTRODE | Katecho, Inc. | 2000-11-07 | Traditional | PDF ↗ |
| K001980 | ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110 | Aspect Medical Systems, Inc. | 2000-09-27 | Traditional | PDF ↗ |
| K002734 | ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106 | Aspect Medical Systems, Inc. | 2000-09-14 | Special | PDF ↗ |
| K001117 | COMFORT STIM | R & D Medical Products, Inc. | 2000-07-05 | Traditional | PDF ↗ |
| K000947 | ULTRASTIM ELECTRODE, MODEL US4040 | Axelgaard Mfg. Co., Ltd. | 2000-06-16 | Traditional | PDF ↗ |
| K001055 | MODEL 4300 PSARRAY EEG ELECTRODE SET | Physiometrix, Inc. | 2000-05-11 | Traditional | PDF ↗ |
| K000865 | QUIK-CAP | Neuroscan | 2000-04-18 | Traditional | PDF ↗ |
| K994330 | ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076 | Aspect Medical Systems, Inc. | 2000-01-18 | Special | PDF ↗ |
| K993130 | ULTRA-GARMENT ELECTRODE | Newwave Medical, LLC | 1999-12-17 | Traditional | PDF ↗ |
| K983097 | TENS/FES/NMES ELECTRODES | Uni-Patch, Inc. | 1999-09-17 | Traditional | PDF ↗ |
| K991772 | CUTANEOUS (DISC) ELECTRODE | Neuro Supplies, Inc. | 1999-08-18 | Traditional | PDF ↗ |
| K991770 | CUTANEOUS (GROUND) ELECTRODE | Neuro Supplies, Inc. | 1999-08-18 | Traditional | PDF ↗ |
| K991769 | CUTANEOUS (BAR) ELECTRODE | Neuro Supplies, Inc. | 1999-08-18 | Traditional | PDF ↗ |
| K991771 | DIGITAL RING ELECTRDE | Neuro Supplies, Inc. | 1999-08-18 | Traditional | PDF ↗ |
| K991199 | BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150 | Biomed Products | 1999-06-22 | Traditional | PDF ↗ |
| K982096 | DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO | Rapid Mfg. Co. | 1999-06-18 | Abbreviated | PDF ↗ |
| K982053 | EEG ELECTRODES MODEL 445 SERIES | Class A Ent. | 1999-04-20 | Traditional | PDF ↗ |
| K990370 | MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/NMES) | Msb,Uk | 1999-04-12 | Traditional | PDF ↗ |
| K983741 | EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020 | Axelgaard Mfg. Co., Ltd. | 1998-12-18 | Traditional | PDF ↗ |
| K980410 | SLE ELECTRODES AND ACCESSORIES | Specialized Laboratory Equipment, Ltd. | 1998-10-22 | Traditional | PDF ↗ |
| K971914 | TECA NCS ELECTRODE SYSTEM 2000 | Medelec, Inc. D.B.A. Teca Corp. | 1998-03-26 | Traditional | PDF ↗ |
| K980229 | MSB TENS ELECTRODES (DISPOSABLE) | Msb , Ltd. | 1998-02-27 | Traditional | PDF ↗ |
| K972122 | DREAM CATCHER | Rest Technologies, Inc. | 1997-08-29 | Traditional | PDF ↗ |
| K970639 | NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K | Medicotest, Inc. | 1997-05-15 | Traditional | PDF ↗ |
| K970426 | VALUETRODE | Axelgaard Mfg. Co., Ltd. | 1997-05-09 | Traditional | PDF ↗ |
| K965194 | MEDICOM, TENS ELECTRODES | Medicotest A/S | 1997-03-06 | Traditional | PDF ↗ |
| K964433 | AQUABOND ELECTRODE | Medibond , Ltd. | 1997-01-27 | Traditional | PDF ↗ |
| K962283 | EEG ELECTRODES | Teca, Inc. | 1996-12-16 | Traditional | PDF ↗ |
| K963236 | M & R DISPOSABLE ELECTRODE (14200) | M & R Mfg., Inc. | 1996-11-15 | Traditional | PDF ↗ |
| K961821 | ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR | Aspect Medical Systems, Inc. | 1996-10-04 | Traditional | PDF ↗ |
| K961609 | MODEL 1220, OR E-NET (54-62 CM) | Physiometrix, Inc. | 1996-05-10 | Traditional | PDF ↗ |
| K961141 | EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220 | Uni-Patch, Inc. | 1996-05-10 | Traditional | PDF ↗ |
| K960885 | MODEL 1240, SMALL E NET | Physiometrix, Inc. | 1996-04-26 | Traditional | PDF ↗ |
| K960873 | MODEL 1210, MEDIUM E-NET | Physiometrix, Inc. | 1996-04-26 | Traditional | PDF ↗ |
| K960732 | HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500 | Physiometrix, Inc. | 1996-04-15 | Traditional | PDF ↗ |
| K953356 | EMG RECORDING RING ELECTRODE | Chalgren Enterprises, Inc. | 1996-01-22 | Traditional | PDF ↗ |
| K953361 | EMG DISC RECORDING ELECTRODE | Chalgren Enterprises, Inc. | 1996-01-22 | Traditional | PDF ↗ |
| K953354 | EMG DISC RECORDING ELECTRODE | Chalgren Enterprises, Inc. | 1996-01-22 | Traditional | PDF ↗ |
| K944314 | DISPOSABLE TM-E COCHGTRODE - BLSC PART NO. 101123 | Bio-Logic Systems Corp. | 1996-01-03 | Traditional | PDF ↗ |
| K952690 | EMG DISC RECORDING ELECTRODE WITH PIN | Chalgren Enterprises, Inc. | 1995-12-06 | Traditional | PDF ↗ |
| K952908 | EMG DISC RECORDING ELECTRODE WITH PIN | Chalgren Enterprises, Inc. | 1995-12-06 | Traditional | PDF ↗ |
| K943449 | NEUROLOGICAL DIAGNOSTIC DEVICES | Henley Intl. | 1995-11-15 | Traditional | PDF ↗ |
| K953219 | 22MM STAINLESS STEEL DISC ELECTRODE, WITH PIN | Chalgren Enterprises, Inc. | 1995-10-06 | Traditional | PDF ↗ |
| K953220 | 32MM NICKEL PLATED DISC ELECTRODE | Chalgren Enterprises, Inc. | 1995-10-06 | Traditional | PDF ↗ |
| K952176 | DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-K | Medicotest, Inc. | 1995-09-25 | Traditional | PDF ↗ |
| K944543 | BIOFLEX GARMENTS, ASSORTED MODELS | Bioflex, Inc. | 1995-07-19 | Traditional | PDF ↗ |
| K950782 | MEDI-TRAC EEG ELECTRODE | Graphic Controls Corp. | 1995-06-22 | Traditional | PDF ↗ |
| K946318 | MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE | Physiometrix, Inc. | 1995-04-24 | Traditional | PDF ↗ |
| K950491 | RICH-MAR CARBON ELECTRODES | Rich-Mar Corp. | 1995-03-29 | Traditional | PDF ↗ |
| K943009 | SMD ELECTRODES | Scientific Medical Devices, Inc. | 1995-02-21 | Traditional | PDF ↗ |
| K944487 | ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES | Prizm Medical, Inc. | 1995-02-21 | Traditional | PDF ↗ |
| K941986 | CUTANEOUS ELECTRODE | Maxxim Medical | 1995-02-21 | Traditional | PDF ↗ |
| K941799 | DISPOSABLE CUTANEOUS ELECTRODES | Bio-Logic Systems Corp. | 1995-02-03 | Traditional | PDF ↗ |
| K942921 | NEUROLINK EEG/EP/EMG SURFACE ELECTRODES | Neuro Supplies, Inc. | 1995-01-31 | Traditional | PDF ↗ |
| K933808 | EEG CUP ELECTRODE | Cadwell Laboratories, Inc. | 1994-12-29 | Traditional | PDF ↗ |
| K933805 | RING ELECTRODE | Cadwell Laboratories, Inc. | 1994-12-19 | Traditional | PDF ↗ |
| K944603 | CONMED VERSA STEM NEUROMUSCULAR STIMULATION/TENS | Conmedcorp | 1994-12-15 | Traditional | PDF ↗ |
| K943126 | ELECTROFLEX | Medical Devices, Inc. | 1994-12-05 | Traditional | PDF ↗ |
| K940012 | SMARTBRACE ELECTRODE | Medical Devices, Inc. | 1994-12-05 | Traditional | PDF ↗ |
| K941568 | K-10-VS, DA-05-VS, RECORDING ELECTRODES | Medicotest, Inc. | 1994-11-04 | Traditional | PDF ↗ |
| K933801 | ELECTRODE, CUTANEOUS | Cadwell Laboratories, Inc. | 1994-10-21 | Traditional | PDF ↗ |
| K942461 | NEUROLOGY ACCESSORIES - MARK-EASY 10-20 | Optimit USA, Inc. | 1994-10-19 | Traditional | PDF ↗ |
| K934580 | DANTEC 13R45 BAR ELECTRODE | Dantec Medical, Inc. | 1994-09-26 | Traditional | PDF ↗ |
| K942718 | CLOTH TENS/BNES ELECTRODE | Conmed Andover Medical, Inc. | 1994-09-22 | Traditional | PDF ↗ |
| K933802 | CUTANEOUS ELECTRODE | Cadwell Laboratories, Inc. | 1994-09-07 | Traditional | PDF ↗ |
| K933807 | GROUND PLATE ELECTRODE | Cadwell Laboratories, Inc. | 1994-07-26 | Traditional | PDF ↗ |
| K933803 | DISPOSABLE TAB ELECTRODE | Cadwell Laboratories, Inc. | 1994-07-08 | Traditional | PDF ↗ |
| K932299 | ELECTRO-MESH | Prizm Medical, Inc. | 1994-07-01 | Traditional | PDF ↗ |
| K936101 | CONMED VERSA-STIM NEUROMUSCULAR STIMULATION ELECTRODE | Conmedcorp | 1994-06-30 | Traditional | PDF ↗ |
| K940704 | CONMED VERSA-STIM INTERFERENTIAL ELECTRODE | Conmedcorp | 1994-06-22 | Traditional | PDF ↗ |
| K931426 | NF-11-E DISPOSABLE REFERENCE/RECORDING ELECTRODE | Medicotest, Inc. | 1993-12-21 | Traditional | PDF ↗ |
| K931430 | CUTANEOUS ELECTRODE | Medicotest, Inc. | 1993-12-21 | Traditional | PDF ↗ |
| K933814 | PHOTOSTRESS RECOVERY TESTER | Storz Instrument Co. | 1993-12-08 | Traditional | PDF ↗ |
| K931925 | TPK CUTANEOUS ELECTRODE | Staodyne, Inc. | 1993-08-16 | Traditional | PDF ↗ |
| K922393 | EMITENS ELECTRODES | Electronic Monitors, Inc. | 1993-07-21 | Traditional | PDF ↗ |
| K915864 | MONOTRODE CUTANEOUS ELECTRODE | Henley Intl. | 1993-07-21 | Traditional | PDF ↗ |
| K924473 | DISPOSABLE THERAPY ELECTRODE | Zimmer Elektromedizin GmbH | 1993-05-19 | Traditional | PDF ↗ |
| K925706 | REUSABLE FINGER CLIP RECORDING ELECTRODE | Chalgren Enterprises, Inc. | 1993-02-10 | Traditional | PDF ↗ |
| K920674 | ELECTROLINK | Kold Products | 1993-01-28 | Traditional | PDF ↗ |
| K912210 | PRO-CHILL STIMPACK | Tko, Inc. | 1992-11-27 | Traditional | PDF ↗ |
| K920264 | BIO-DETEK TRACERITE EEG ELECTRODE | Bio-Detek, Inc. | 1992-06-02 | Traditional | PDF ↗ |
| K912643 | ELECTRODE | Skylark Device Co., Ltd. | 1992-02-14 | Traditional | PDF ↗ |
| K913031 | K-STIM | Katecho, Inc. | 1992-01-30 | Traditional | PDF ↗ |
| K915333 | ELECTRODE USING PROMEON RG-60 SERIES GEL | Labeltape Meditect, Inc. | 1992-01-14 | Traditional | PDF ↗ |
| K914384 | MEDICAL DESIGNS REUSABLE CARBON RUBBER ELECTRODE | Medical Design & Manufacturing Corp. | 1991-11-13 | Traditional | PDF ↗ |
Product code GXY · Class II · Neurology. Data: openFDA.