Stimulator, Nerve, Transcutaneous, For Pain Relief
Regulation 882.5890
2510(k)s in 12 months (606 all time)
0recalls in 12 months (7 all time)
4recalls that name a 510(k)
Top companies in GZJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomedical Life Systems | 22 | 0 |
| Empi | 17 | 0 |
| Medical Devices, Inc. | 16 | 0 |
| American Imex | 11 | 0 |
| Bio-Medical Research, Ltd. | 10 | 0 |
| Henley Intl. | 10 | 0 |
| Medtronic Vascular | 10 | 0 |
| Skylark Device Co., Ltd. | 10 | 0 |
| Apex Medical Corp. | 8 | 0 |
| Monad Corp. | 8 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 11, 1988 | K880980 | SCHULDT* PC* - DUAL CHANNEL TENS Schuldt Laboratories, Inc., CA | GZJ |
| Apr 6, 1988 | K880751 | ULTIMA XS (TENS) American Imex | GZJ |
| Mar 24, 1988 | K880452 | LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE Lumiscope Co., Inc. | GZJ |
| Jan 22, 1988 | K872704 | AMASTIM 2000 Amatech International, Inc. | GZJ |
| Dec 18, 1987 | K873190 | MEC-I-TRON, MODEL P-1 Meyer Equipment Company, Inc. | GZJ |
| Dec 11, 1987 | K874085 | REBUILDER(TM) Micromed, Inc. | GZJ |
| Nov 20, 1987 | K874550 | TX-4(TENS) (SIGMA TENS) Oms Medico, Inc. | GZJ |
| Nov 20, 1987 | K874333 | TX-2(TENS) Oms Medico, Inc. | GZJ |
| Oct 26, 1987 | K873357 | ELECTROBLOC TRANS. ELECTRICAL NERVE BLOCK GENERA. Th Charters, Inc. | GZJ |
| Oct 8, 1987 | K873420 | GLOBALCARE(TENS) Oms Medico, Inc. | GZJ |
| Sep 16, 1987 | K873484 | 120Z(TENS) Oms Medico, Inc. | GZJ |
| Aug 4, 1987 | K872657 | ULTRAPAC II SX PLUS (TM) Medical Devices, Inc. | GZJ |
| Jul 29, 1987 | K872398 | T.E.N.S. DEVICE MODEL SPL 2000 Spartan Laboratories, Inc. | GZJ |
| Jul 27, 1987 | K872399 | T.E.N.S. DEVICE MODEL SPL 2000S Spartan Laboratories, Inc. | GZJ |
| Jul 21, 1987 | K871722 | MEDTENS(TM), MODEL NUMBER 7725 Medtronic Vascular | GZJ |
| Jun 25, 1987 | K871699 | TX-3(TENS) Oms Medico, Inc. | GZJ |
| Jun 25, 1987 | K871666 | MODEL HP (OR MODEL 1001) TRANSCUTANEOUS STIMULATOR Oriental Medical Supplies, Inc. | GZJ |
| Jun 11, 1987 | K871396 | ACCULATOR 287EP Accu Science Corp. | GZJ |
| Jun 2, 1987 | K871126 | ELECTRO-NERVE STIMULATOR TENS MODEL C & B11, B11C Biomedical Life Systems, Inc. | GZJ |
| Jun 2, 1987 | K871125 | ELECTRO-NERVE STIMULATOR TENS MODEL B5/SKN Biomedical Life Systems, Inc. | GZJ |
| Apr 22, 1987 | K870667 | OMEGA T200 Henley Intl. | GZJ |
| Apr 22, 1987 | K870666 | OMEGA T100 Henley Intl. | GZJ |
| Apr 10, 1987 | K864370 | DYNATRON 1120 EPS (ELECTRICAL POINT STIMULATOR) Dynatronics Laser Corp. | GZJ |
| Apr 1, 1987 | K870168 | EMPI LOGIX MODEL 712 NMS, TENS Empi | GZJ |
| Apr 1, 1987 | K864114 | TENS DEVICE FOR RELIEF OF CHRONIC PAIN Futuremed Div. of Future Impex Corp. | GZJ |
| Mar 25, 1987 | K862454 | AGAR 7K TENS INSTRUMENT Solcoor, Inc. | GZJ |
| Mar 17, 1987 | K870583 | NEU-PULS(TENS) MODEL #295 Oms Medico, Inc. | GZJ |
| Mar 17, 1987 | K865063 | UNI-PULS(TENS) MODEL #292 Oms Medico, Inc. | GZJ |
| Mar 13, 1987 | K864968 | BACPAC (TM), MODEL 6500 Medical Devices, Inc. | GZJ |
| Mar 9, 1987 | K864956 | DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA. La Jolla Technology, Inc. | GZJ |
| Feb 26, 1987 | K865048 | ECLIPSE+, MODEL NUMBER 7723 Medtronic Vascular | GZJ |
| Feb 26, 1987 | K864368 | SCHULDT* PLUS 8 T.E.N.S. DEVICE Schuldt Laboratories, Inc., CA | GZJ |
| Feb 20, 1987 | K864735 | A-TENS - MODEL AI-87 American Imex | GZJ |
| Feb 20, 1987 | K863469 | CODETRON TRANSCUTANEOUS ELECTRICAL NERVE STIMULA. Cordis Corp. | GZJ |
| Feb 4, 1987 | K862352 | ACCULATOR 487E Accu Science Corp. | GZJ |
| Dec 22, 1986 | K862602 | AXION IV GOLDLINE SERIES Ventura Medical Electronics | GZJ |
| Nov 25, 1986 | K862450 | MEDA 2500 T.E.N.S. Watlow/Winona, Inc. | GZJ |
| Oct 24, 1986 | K863568 | 'MYOSTIM EX' Electro Therapeutic Devices, Inc., CA | GZJ |
| Oct 24, 1986 | K863567 | 'TENSAID' Electro Therapeutic Devices, Inc., CA | GZJ |
| Sep 9, 1986 | K861896 | UNI-TENS XL TENS Solcoor, Inc. | GZJ |
| Sep 9, 1986 | K861895 | UNI-TENS Solcoor, Inc. | GZJ |
| Sep 9, 1986 | K861894 | AGAR 9K TENS Solcoor, Inc. | GZJ |
| Aug 19, 1986 | K862355 | TRANS-PULSE MODEL #1103 The Sun Co. | GZJ |
| Aug 18, 1986 | K862337 | ULTRAPAC II SD (TM) Medical Devices, Inc. | GZJ |
| Aug 14, 1986 | K861119 | WALLANT NEUROLOGIX DUAL PUR NERVE/NEUROMUSCU STIMU Wallant Intl. Trade, Inc. | GZJ |
| Aug 7, 1986 | K860847 | WALLANT NEUROLOGIX GENERAL PURPOSE TENS Wallant Intl. Trade, Inc. | GZJ |
| Jul 18, 1986 | K852061 | PULSAR NEUROSTIMULATOR Andromeda Research, Inc. | GZJ |
| Jul 15, 1986 | K861830 | EMPI MODEL GLS 450, TENS Empi | GZJ |
| Jul 3, 1986 | K861451 | EMPI MODEL 720 NMS, TENS Empi | GZJ |
| Jun 18, 1986 | K861214 | SKYLARK GB 1000 Peleg Intl. Co., CA | GZJ |
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