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 5 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K832145 | MONOBLOCK PROSTOPERATIVE TENS ELECTRODE | New Dimensions IN Medicine, Inc. | 1983-07-19 | Traditional | PDF ↗ |
| K831785 | NEURO EASE | Andover Medical, Inc. | 1983-06-30 | Traditional | PDF ↗ |
| K831104 | TENZCARE MUSCLE STIMULATION ELECTRODES | 3M Company | 1983-05-09 | Traditional | PDF ↗ |
| K831046 | ELECTRODE 3799 | Medtronic Vascular | 1983-04-26 | Traditional | PDF ↗ |
| K830798 | STERILE SURGICAL PAIN RELIEF ELECTRODE | Lectec Corp. | 1983-04-05 | Traditional | PDF ↗ |
| K830600 | REFERENCE & MONITORING ELECTRODE | Precision Cap Systems | 1983-03-24 | Traditional | PDF ↗ |
| K830597 | BABY CAP, ELECTRODE SET & BOARD ADAPTOR | Precision Cap Systems | 1983-03-24 | Traditional | PDF ↗ |
| K830601 | FOAMIES DIAPOS. FOAM RUBBER PADS | Precision Cap Systems | 1983-03-24 | Traditional | PDF ↗ |
| K830521 | PRECISION EEG CAP W/ELECTRODE SET AND | Precision Cap Systems | 1983-03-24 | Traditional | PDF ↗ |
| K830599 | LOCALIZING ELECTRODE | Precision Cap Systems | 1983-03-24 | Traditional | PDF ↗ |
| K830598 | EVOKED POTENTIAL CAP W/EVOKED POTENTIAL | Precision Cap Systems | 1983-03-24 | Traditional | PDF ↗ |
| K830602 | PRECISION CAP STRAPS | Precision Cap Systems | 1983-03-24 | Traditional | PDF ↗ |
| K822378 | TENS ELECTRODE | Franklin Sales & Mfg. Co. | 1982-08-24 | Traditional | PDF ↗ |
| K822224 | EMPI SINGLE USE | Empi | 1982-08-16 | Traditional | PDF ↗ |
| K820876 | MODEL 3854 ELECTRODE | Medtronic Vascular | 1982-04-21 | Traditional | PDF ↗ |
| K820082 | POST-OP ELECTRODE (TENS ELECTRODE) | Consolidated Medical Equipment, Inc. | 1982-01-28 | Traditional | PDF ↗ |
| K812418 | MEDTRONIC #3798 ELECTRODE | Medtronic Vascular | 1981-09-16 | Traditional | PDF ↗ |
| K812299 | ELECTRO-SNAP | Rodel Products Corp. | 1981-09-11 | Traditional | PDF ↗ |
| K810206 | DUAL TYPE ELECTRODE | Professional Instruments Co. | 1981-03-20 | Traditional | PDF ↗ |
| K810262 | AUTOMATIC ELECTRODE PLACEMENT BELT | Wallant Intl. Trade, Inc. | 1981-03-11 | Traditional | PDF ↗ |
| K803012 | SHUR-PATCH TAPE PATCH | Shur Medical Corp. | 1980-12-30 | Traditional | PDF ↗ |
| K800117 | TRU-PULSE PADS | Ipco Corp. | 1980-02-11 | Traditional | PDF ↗ |
| K792351 | MEDTRONIC MOD. 3852 STERIL-ICE ELECTRODE | Medtronic Vascular | 1979-12-05 | Traditional | PDF ↗ |
| K791097 | CEPTORTRODE WITH CEPTOR HESIVE | Med General | 1979-08-03 | Traditional | PDF ↗ |
| K790850 | T.E.N.S.* SINGLE-USE ELECTRODE | 3M Company | 1979-05-31 | Traditional | PDF ↗ |
| K790542 | ELECTRODES, STAODERM STERILE | Staodynamics, Inc. | 1979-05-23 | Traditional | PDF ↗ |
| K790316 | ELECTRODE, ELECTROFLEX | Andover Medical, Inc. | 1979-03-27 | Traditional | PDF ↗ |
| K790345 | STIMTECH TENS ELECTRODE | Stimulation Technology, Inc. | 1979-03-21 | Traditional | PDF ↗ |
| K790269 | CEPTOR HESIVE | Med General | 1979-02-26 | Traditional | PDF ↗ |
| K782137 | MEDTRONIC MODEL 3797 ELECTRODE | Medtronic Vascular | 1979-02-07 | Traditional | PDF ↗ |
| K781494 | EEG LEAD ASSEMBLY | Graphic Controls Corp. | 1978-10-31 | Traditional | PDF ↗ |
| K781314 | THERAPY UNIT & ELECTRODIAG. | General Theraphysical, Inc. | 1978-10-03 | Traditional | PDF ↗ |
| K780537 | EAR ELECTRODE-ADULT & PEDIATRIC | Life-Tech Instruments, Inc. | 1978-06-02 | Traditional | PDF ↗ |
| K780045 | ELECTRODE CAP | Electro-Cap Intl., Inc. | 1978-01-24 | Traditional | PDF ↗ |
| K771719 | KARAYA ELECTRODES | Lectec Corp. | 1977-09-20 | Traditional | PDF ↗ |
| K770447 | EPC INSTICKS | Stimulation Technology, Inc. | 1977-03-15 | Traditional | PDF ↗ |
| K770448 | INS - T.E.N.S. | Stimulation Technology, Inc. | 1977-03-15 | Traditional | PDF ↗ |
| K770323 | VERI/TRODES | Verite Scientific, Inc. | 1977-02-28 | Traditional | PDF ↗ |
| K760947 | PREGELLED DISPOSABLE ELECTRODE | Texas Instruments, Inc. | 1976-11-09 | Traditional | PDF ↗ |
| K760312 | ELECTRODE, PNS | Ndm Corp. | 1976-08-04 | Traditional | PDF ↗ |
Product code GXY · Class II · Neurology. Data: openFDA.