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 4 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K911366 | PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE | Medical Design & Manufacturing Corp. | 1991-09-27 | Traditional | PDF ↗ |
| K913373 | GLOBALCARE ELECTRODE | Globalcare Intl., Inc. | 1991-08-29 | Traditional | PDF ↗ |
| K911989 | GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT. | Somnitec, Inc. | 1991-07-30 | Traditional | PDF ↗ |
| K911069 | VERSA-STIM ELECTRODE LINE MODIFIED | Conmedcorp | 1991-07-16 | Traditional | PDF ↗ |
| K905539 | 3M 6830 ELECTRODE | 3M Healthcare | 1991-05-28 | Traditional | PDF ↗ |
| K903554 | NORTECH MODEL 87202204 ELECTRODE | Medtronic Andover Medical, Inc. | 1990-08-30 | Traditional | PDF ↗ |
| K903402 | GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L | Medi-Source, Inc. | 1990-08-22 | Traditional | PDF ↗ |
| K903427 | NORTECH MODEL 86901000 ELECTRODE | Andover Medical, Inc. | 1990-08-17 | Traditional | PDF ↗ |
| K902719 | SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT | Labeltape Meditect, Inc. | 1990-07-19 | Traditional | PDF ↗ |
| K901809 | LUMISCOPE ELECTRODES MODELS EL-08,11,15,06,21,25 | Lumiscope Co., Inc. | 1990-06-18 | Traditional | PDF ↗ |
| K902195 | TBD TENS REUSABLE ELECTRODE | Empi | 1990-06-08 | Traditional | PDF ↗ |
| K901575 | REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD | Pioneering Technologies, Inc. | 1990-05-02 | Traditional | PDF ↗ |
| K900825 | 'POLYSTIM' | Medical Science Products, Inc. | 1990-04-10 | Traditional | PDF ↗ |
| K901102 | MODIFIED ISLAND PIN TENS DISPOSABLE ELECTRODE | Empi | 1990-03-23 | Traditional | PDF ↗ |
| K901103 | MODIFIED ISLAND SNAP TENS DISPOSABLE ELECTRODE | Empi | 1990-03-23 | Traditional | PDF ↗ |
| K896766 | TD-28 DISPOSABLE ELECTRODE | Med USA | 1990-03-14 | Traditional | PDF ↗ |
| K900997 | K-STERILE TENS ELECTRODES | Katecho, Inc. | 1990-03-13 | Traditional | PDF ↗ |
| K900606 | 'CONDUCTOR' DISPOSABLE TENS ELECTRODE | Medical Science Products, Inc. | 1990-03-13 | Traditional | PDF ↗ |
| K900656 | SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT. | Labeltape Meditect, Inc. | 1990-03-01 | Traditional | PDF ↗ |
| K900059 | BIOPOTENTIAL SURFACE ELECTRODE | Integral Design, Inc. | 1990-02-22 | Traditional | PDF ↗ |
| K896844 | BABE-EASE NEONATAL CLOTH ECG ELECTRODE | Labeltape Meditect, Inc. | 1990-02-12 | Traditional | PDF ↗ |
| K896936 | L.A.S.P. LUMBAR AND SACRAL PAD, REPOSITION. SNAP | Labeltape Meditect, Inc. | 1990-01-22 | Traditional | PDF ↗ |
| K896485 | MODIFIED ISLAND TENS DISP. ELECTRODE FOR SNAP CONN | Empi | 1989-12-21 | Traditional | PDF ↗ |
| K893793 | TENZCARE ELECTRODE 6862 | 3M Company | 1989-11-27 | Traditional | PDF ↗ |
| K895081 | PROMONTORY STIMULATING ELECTRODE | Cadwell Laboratories, Inc. | 1989-11-09 | Traditional | PDF ↗ |
| K890981 | ELECTRO-TOUCH (ET) GLOVE | Psychoenergetic Systems, Inc. | 1989-10-19 | Traditional | PDF ↗ |
| K895604 | SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES | Medical Design & Manufacturing Corp. | 1989-10-13 | Traditional | PDF ↗ |
| K894042 | SPECT.E.N.S. REPOSITIONABLE, PIN TYPE, TENS | Labeltape Meditect, Inc. | 1989-08-11 | Traditional | PDF ↗ |
| K894043 | SPECT.E.N.S REPOSITIONABLE, SNAP-TYPE, TENS | Labeltape Meditect, Inc. | 1989-08-11 | Traditional | PDF ↗ |
| K891107 | INDICATENS INDICATOR ELECTRODE MODEL 2 | Acudata Software | 1989-05-25 | Traditional | PDF ↗ |
| K891105 | INDICATENS MODEL 4X4 SP ELECTRODE STIM. PATCHES | Acudata Software | 1989-05-25 | Traditional | PDF ↗ |
| K890747 | EMPI REUSEABLE PIN-STYLE TENS ELECTRODE | Empi | 1989-03-16 | Traditional | PDF ↗ |
| K890614 | EMPI MULTIDAY TENS DISPOSABLE ELECTRODE | Empi | 1989-03-16 | Traditional | PDF ↗ |
| K890605 | EMPI ISLAND TENS ELECTRODE | Empi | 1989-03-16 | Traditional | PDF ↗ |
| K890710 | DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS | Somatics, Inc. | 1989-03-14 | Traditional | PDF ↗ |
| K884814 | BIOTENS | Trekk Intl. | 1989-02-27 | Traditional | PDF ↗ |
| K884348 | MODIFIED JELTRODE(TM) ELECTRODES DEEMED | Henley Intl. | 1988-12-15 | Traditional | PDF ↗ |
| K882464 | DTL MICROTOUCH EYE ELECTRODE | Lectromedics, Inc. | 1988-11-15 | Traditional | PDF ↗ |
| K882888 | MULTIDAY, MODELS 8300 AND 8310 | Medical Devices, Inc. | 1988-09-30 | Traditional | PDF ↗ |
| K882887 | PROGEL(TM), MODELS 8630 AND 8635 | Medical Devices, Inc. | 1988-09-29 | Traditional | PDF ↗ |
| K882886 | PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535 | Medical Devices, Inc. | 1988-09-29 | Traditional | PDF ↗ |
| K882809 | THYMAPAD | Somatics, Inc. | 1988-09-27 | Traditional | PDF ↗ |
| K881749 | STRAIGHT-LINE FINISH FOR IMPLANTABLE PULSE GENERA. | Medtronic Vascular | 1988-07-18 | Traditional | PDF ↗ |
| K881872 | TENS ELECTRODE MODEL 238P | Lectec Corp. | 1988-06-16 | Traditional | PDF ↗ |
| K881871 | SPARE MS 700 TENS ELECTRODE | Lectec Corp. | 1988-06-16 | Traditional | PDF ↗ |
| K881444 | T.E.N.S. ELECTRODE NON-STERILE | Tens Accessories, Inc. | 1988-06-10 | Traditional | PDF ↗ |
| K880545 | STIMWEAR GARMENTS, SIGNAL I AND SIGNAL II | Stimwear | 1988-05-31 | Traditional | PDF ↗ |
| K881343 | DURADERM BUTTERFLY | Sentry Medical Products, Inc. | 1988-05-04 | Traditional | PDF ↗ |
| K880649 | TENS ELECTRODE SNAP TYPE, DISPOSA., SELF-ADHERING | Labeltape Meditect, Inc. | 1988-03-04 | Traditional | PDF ↗ |
| K874469 | TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) | Axelgaard Mfg. Co., Ltd. | 1988-01-28 | Traditional | PDF ↗ |
| K875284 | MEDTRONIC SNAP EASE MODEL 7795 CUTANEOUS ELECTRODE | Medtronic Vascular | 1988-01-28 | Traditional | PDF ↗ |
| K874735 | DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE | Dantec Electronics, Inc. | 1988-01-22 | Traditional | PDF ↗ |
| K873298 | ELEC-TIP | Etymotic Research | 1987-11-24 | Traditional | PDF ↗ |
| K874075 | PT-100-30 SOMATOSENSORY STIMULATING ELECTRODE | Weaver & Co. | 1987-10-20 | Traditional | PDF ↗ |
| K872976 | TENS PALS PLUS | Axelgaard Mfg. Co., Ltd. | 1987-09-22 | Traditional | PDF ↗ |
| K872250 | LECTEC STIMULATING ELECTRODE | Lectec Corp. | 1987-08-07 | Traditional | PDF ↗ |
| K872574 | TENSAGAIN | Ferris Mfg. Corp. | 1987-07-23 | Traditional | PDF ↗ |
| K872492 | ALTERNATE SUPPLIERS FOR TENS ELECTRODE | Franklin Sales & Mfg. Co. | 1987-07-22 | Traditional | PDF ↗ |
| K872044 | CARBON ELECTRODE | Futuremed Div. of Future Impex Corp. | 1987-07-16 | Traditional | PDF ↗ |
| K871292 | HEALTH CONCEPTS CONDUCTIVE MEMBRANE | Health Concepts, Inc. | 1987-06-02 | Traditional | PDF ↗ |
| K871222 | TANTONE MULTI-DAY #633 TENS ELECTRODE | Uni-Patch, Inc. | 1987-05-29 | Traditional | PDF ↗ |
| K871026 | DISPOSABLE, PIN-CONN. POLYMER-GEL ELECT. FOR TENS | Labeltape Meditect, Inc. | 1987-04-22 | Traditional | PDF ↗ |
| K870160 | DYNEX DISPOSABLE SELF-ADHERING ELECTRODE W/TENS | La Jolla Technology, Inc. | 1987-04-01 | Traditional | PDF ↗ |
| K864973 | TENZCARE(TM) SNAP ELECTRODE 6867 | 3M Company | 1987-01-20 | Traditional | PDF ↗ |
| K864032 | EM TENS WINDOW ELECTRODES | Electromed Intl., Ltd. | 1986-12-22 | Traditional | PDF ↗ |
| K862377 | QMED SELF ADHERING ELECTRODE | Qmed, Inc. | 1986-09-26 | Traditional | PDF ↗ |
| K863307 | TENZCARE SNAP ELECTRODE, NO. 6865 | 3M Company | 1986-09-23 | Traditional | PDF ↗ |
| K863035 | POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER | Valleylab, Inc. | 1986-09-18 | Traditional | PDF ↗ |
| K862718 | VERSA STIM | Conmedcorp | 1986-09-09 | Traditional | PDF ↗ |
| K862231 | EMPI, MODEL 1000 HAND HELD ELECTRODE | Empi | 1986-08-27 | Traditional | PDF ↗ |
| K862028 | ULTRAHESIVE II POSTOP ELECTRODE | Medical Devices, Inc. | 1986-08-01 | Traditional | PDF ↗ |
| K862011 | MULTI-DAY ELECTRODES | Medical Electronic Assn. | 1986-07-03 | Traditional | PDF ↗ |
| K861956 | JELTRODE | Henley Intl. | 1986-06-26 | Traditional | PDF ↗ |
| K854204 | DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENS | La Jolla Technology, Inc. | 1986-01-10 | Traditional | PDF ↗ |
| K854513 | EMPI, NMS/SUE CUTANEOUS ELECTRODE | Empi | 1985-12-06 | Traditional | PDF ↗ |
| K853633 | TENS CONDUCTIVE MEDIA PAD | Alternative Design Systems, Inc. | 1985-12-03 | Traditional | PDF ↗ |
| K853552 | SENTRY FLEXIBLE TENS | Sentry Medical Products, Inc. | 1985-09-26 | Traditional | PDF ↗ |
| K850646 | ECLIPSE SELF ADHERING ELECTRODE | Todd Medical, Inc. | 1985-09-03 | Traditional | PDF ↗ |
| K852298 | TENS-AID STERILE ELECTRODES FOR POST-OP TENS | Staodynamics, Inc. | 1985-06-24 | Traditional | PDF ↗ |
| K851175 | TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE | Medical Devices, Inc. | 1985-06-18 | Traditional | PDF ↗ |
| K852267 | ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES | Axelgaard Mfg. Co., Ltd. | 1985-06-18 | Traditional | PDF ↗ |
| K851303 | COMFORT-EASE ELECTRODE | Medtronic Vascular | 1985-05-23 | Traditional | PDF ↗ |
| K850108 | EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG | Nicolet Biomedical Instruments | 1985-04-11 | Traditional | PDF ↗ |
| K850131 | CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS | Consolidated Medical Equipment, Inc. | 1985-03-05 | Traditional | PDF ↗ |
| K850311 | DISPOS. CONDUCTIVE ADHESIVE TENS PAD | Consolidated Medical Equipment, Inc. | 1985-03-05 | Traditional | PDF ↗ |
| K843964 | TENS-AID PREMIUM ELECTRODES | Staodynamics, Inc. | 1985-02-25 | Traditional | PDF ↗ |
| K844098 | CANMED 103 | Medtronic Vascular | 1985-02-04 | Traditional | PDF ↗ |
| K844023 | AQUAFORM ELECTRODES WITH AQUAPORE | Biostim, Inc. | 1985-02-01 | Traditional | PDF ↗ |
| K844097 | CANMED 103 9300 ELECTRODE | Medtronic Vascular | 1984-12-11 | Traditional | PDF ↗ |
| K844646 | SIEGEN SURFACE ELECTRODES | Siegen Corp. | 1984-12-11 | Traditional | PDF ↗ |
| K842033 | ELECTRODE PLACEMENT ARM PART GARMENT | Bio-Stimu Trend Corp. | 1984-07-26 | Traditional | PDF ↗ |
| K842271 | ELECTRODE, SURFACE EEG ELECTRODE | Durden Enterprises, Inc. | 1984-07-20 | Traditional | PDF ↗ |
| K841877 | EEG ELECTRODE PAD | Neurologics, Inc. | 1984-07-19 | Traditional | PDF ↗ |
| K841685 | EEG ELECTRODES | Bio-Scan, Inc. | 1984-06-07 | Traditional | PDF ↗ |
| K840396 | ELECTRO-MESH WRAP | Whiting & Davis Co. | 1984-04-30 | Traditional | PDF ↗ |
| K840395 | ELECTRO-MESH GLOVE | Whiting & Davis Co. | 1984-04-30 | Traditional | PDF ↗ |
| K840592 | ELECTRODE PLACEMENT LUMBAR SHORTS | Bio-Stimu Trend Corp. | 1984-03-23 | Traditional | PDF ↗ |
| K840591 | ELECTRODE PLACEMENT SLEEVE | Bio-Stimu Trend Corp. | 1984-03-23 | Traditional | PDF ↗ |
| K832296 | S2 POSTERIOR-TIB | Anstek Corp. | 1983-08-31 | Traditional | PDF ↗ |
| K832295 | S2MEDIAN | Anstek Corp. | 1983-08-31 | Traditional | PDF ↗ |
Product code GXY · Class II · Neurology. Data: openFDA.