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 |
|---|---|---|---|
| May 15, 1996 | K960969 | GALVA 5-T Zimmer Elektromedizin GmbH, DE | GZJ |
| Mar 20, 1996 | K951903 | EPIX XL TENS UNIT Empi | GZJ |
| Jan 22, 1996 | K954334 | ACUPLUS S.H.P. Intl. Pty., Ltd. | GZJ |
| Dec 22, 1995 | K946230 | ENDURA REUSABLE TENS AND NMES ELECTRODES Selectivemed Components, Inc. | GZJ |
| Oct 27, 1995 | K942631 | ELECTROCARE Waco Corp. | GZJ |
| Sep 29, 1995 | K940600 | STIMULATOR, NERVE, TRANSCUTANEOUS, (PAIN RELIEF) 84-GZJ Progressive Concepts, Inc. | GZJ |
| Jun 26, 1995 | K946299 | PGS123 AND HVS-123 Skylark Device Co., Ltd., TW | GZJ |
| Jun 2, 1995 | K941923 | STERILE TREATMENT ELECTRODE Staodyne, Inc. | GZJ |
| Jun 2, 1995 | K933197 | THE SIGNATURE SERIES, M IV Progressive Electrical Therapeutics | GZJ |
| May 15, 1995 | K944280 | TRANSAMERICAN CLASSIC TENS Transamerica Biomedical, Inc. | GZJ |
| Jan 30, 1995 | K945676 | GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES Selectivemed Components, Inc. | GZJ |
| Sep 8, 1994 | K933237 | MEDI-STIM, MODIFICATION Mid-Canada Medical, CA | GZJ |
| Jul 11, 1994 | K934051 | BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD) Skylark Device Co., Ltd., TW | GZJ |
| Jul 1, 1994 | K932897 | TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR Nemectron GmbH | GZJ |
| Jun 9, 1994 | K931079 | STAT-TENS Skylark Device Co., Ltd., TW | GZJ |
| Jun 7, 1994 | K933368 | TENS-IT Electro Med Supply, Inc. | GZJ |
| May 26, 1994 | K935324 | THERAPEUTIC ULTRASOUND AND STIMULATOR Chattanooga Group, Inc. | GZJ |
| Apr 15, 1994 | K935395 | NEURON II AND MICROTENS Datran Corp. | GZJ |
| Mar 23, 1994 | K930102 | PULSATOR 5000 Toys House Industrial Corp. | GZJ |
| Mar 18, 1994 | K932592 | BRACE NEUTRALIZER Smith and Nephew Donjoy, Inc. | GZJ |
| Mar 14, 1994 | K935132 | HOME MICROCURRENT HMC Medical Devices, Inc. | GZJ |
| Feb 23, 1994 | K934619 | FLEXMATE Medical Devices, Inc. | GZJ |
| Feb 22, 1994 | K932854 | EZ GRIP DISPOSABLE ELECTRODES Advanced Adhesives | GZJ |
| Feb 1, 1994 | K931108 | EZ GRIP REUSABLE TENS/NMES ELECTRODES Advanced Adhesives | GZJ |
| Jan 31, 1994 | K932611 | NEUROMUSCULAR STIMULATOR Myo/Kinetic Systems, Inc. | GZJ |
| Jan 27, 1994 | K932849 | PMI TENS ELECTRODE Pepin Mfg., Inc. | GZJ |
| Jan 27, 1994 | K931715 | PURECARE AT-903 T.E.N.S. Fuching Enterprise Co., Ltd. | GZJ |
| Oct 6, 1993 | K932320 | NEUTRALIZER Smith and Nephew Donjoy, Inc. | GZJ |
| Jun 18, 1993 | K931570 | COM-TENS (SINGLE MODE) Ems Dist. | GZJ |
| Jun 4, 1993 | K931424 | MAXIMA I Staodyne, Inc. | GZJ |
| Jun 1, 1993 | K926326 | MICROCARE(TM) American Imex | GZJ |
| May 18, 1993 | K923970 | INTEGRITY 2 Medrotech Corp. | GZJ |
| May 17, 1993 | K922202 | K-STIM CLEAR Katecho, Inc. | GZJ |
| May 13, 1993 | K930865 | STAODYN MAXIMA III Staodyne, Inc. | GZJ |
| May 7, 1993 | K925821 | COMFORTRON M. D. Supply, Inc. | GZJ |
| Apr 15, 1993 | K915663 | TENS PRO 900 Acuhealth (Usa) Pty. , Ltd. | GZJ |
| Mar 18, 1993 | K925686 | THERA PULSE A ELECTRO NERVE STIMULATOR Biomedical Life Systems, Inc. | GZJ |
| Jan 28, 1993 | K925898 | MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUS Staodyne, Inc. | GZJ |
| Jan 22, 1993 | K925729 | SD-602 SD MODE 11, SD-603 SD MOD 111 Skylark Device Co., Ltd., TW | GZJ |
| Dec 3, 1992 | K920266 | TENS MODEL 240Z Oms Medical Supplies, Inc. | GZJ |
| Dec 1, 1992 | K924545 | MICRO MODE-TRANS ELECTRICAL NEURAL STIMULATOR Mod Mode Medical | GZJ |
| Oct 23, 1992 | K923934 | TX-3 SD Skylark Device Co., Ltd., TW | GZJ |
| Oct 15, 1992 | K923935 | SD-605 SD II PROGRAM Skylark Device Co., Ltd., TW | GZJ |
| Oct 13, 1992 | K923298 | MICRO 100,200,300, & 400 TENS Skylark Device Co., Ltd., TW | GZJ |
| Oct 13, 1992 | K922690 | PAIN-EEZ International Center For Nutritional Research | GZJ |
| Oct 13, 1992 | K920260 | INTELECT 600MP Chattanooga Group, Inc. | GZJ |
| Oct 6, 1992 | K921679 | K-DISPERSE Katecho, Inc. | GZJ |
| Oct 5, 1992 | K923255 | Q-SD Quantitative Medicine, Inc. | GZJ |
| Sep 22, 1992 | K921828 | TEAM-MC II Henley Intl. | GZJ |
| Sep 11, 1992 | K921813 | MED-TENS Ems Dist. | GZJ |
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