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 |
|---|---|---|---|
| Feb 2, 2001 | K993229 | ANALGESIC PULSER, MODEL AP-439 Johari Electro-Tech Co., IN | GZJ |
| Jan 24, 2001 | K003487 | STIMATE N601 TENS Everyway Medical Instruments Co.,Ltd, TW | GZJ |
| Jan 12, 2001 | K003258 | MS-ONE, MODEL MS-1 Home Wellness West | GZJ |
| Jan 12, 2001 | K003231 | HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3 Home Medical Services | GZJ |
| Jul 6, 2000 | K994266 | FDTENS 2010 Fuji Dynamics Limited, HK | GZJ |
| Jul 6, 2000 | K994265 | MEDISANA DIGITAL TENS Fuji Dynamics Limited, HK | GZJ |
| Jun 7, 2000 | K984376 | ENDOR 2000 T.C. Medical, Inc. | GZJ |
| Mar 16, 2000 | K994387 | RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL Woodside Biomedical, Inc. | GZJ |
| Feb 11, 2000 | K991397 | TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS Sein Electronics Co., Ltd. | GZJ |
| Dec 9, 1999 | K983907 | RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R Woodside Biomedical, Inc. | GZJ |
| Nov 19, 1999 | K993823 | MED-4000 Micro Current Technology, Inc. | GZJ |
| Nov 9, 1999 | K992709 | 1818 TENS UNIT 138 Medical Supplies, Inc. | GZJ |
| Aug 19, 1999 | K990230 | ELECTRO-NERVE STIMULATOR TENS, MODEL LX Biomedical Life Systems, Inc. | GZJ |
| Jun 7, 1999 | K982961 | MEDIPOINT Medipoint , Ltd. | GZJ |
| Mar 11, 1999 | K982173 | BUZBEE Mwr Electronics Industrial Co., ZA | GZJ |
| Feb 23, 1999 | K982967 | RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R Woodside Biomedical, Inc. | GZJ |
| Feb 10, 1999 | K984025 | CARE TENS Care Rehab, Inc. | GZJ |
| Feb 1, 1999 | K982324 | VECTRA PRO MODELS 2 AND 4 Chattanooga Group, Inc. | GZJ |
| Feb 1, 1999 | K982321 | VECTRA STIM MODELS 200 AND 400 Chattanooga Group, Inc. | GZJ |
| Nov 25, 1998 | K981976 | ACUTRON MENTOR MODEL 961 Microcurrent Research, Inc. | GZJ |
| Nov 6, 1998 | K982410 | SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICE Rehabilicare, Inc. | GZJ |
| Oct 8, 1998 | K982436 | RELIEFBAND NST DEVICE, MODEL #'S WB-2, WB-6 AND WB-R Woodside Biomedical, Inc. | GZJ |
| Sep 22, 1998 | K982221 | PREMIER AP American Imex | GZJ |
| Aug 14, 1998 | K964437 | GB-1002 TENS WITH MASSAGE Skylark Device Co., Ltd., TW | GZJ |
| Jul 29, 1998 | K973980 | ACU-STIM TENS, AP-101082T Apex Medical Corp., TW | GZJ |
| Jul 29, 1998 | K973979 | MULTI-STIM TENS, AP-101081T Apex Medical Corp., TW | GZJ |
| Jul 29, 1998 | K973978 | MICRO II MICROCURRENT TENS Apex Medical Corp., TW | GZJ |
| Feb 27, 1998 | K972244 | NT2000 Bio-Medical Research, Ltd. | GZJ |
| Feb 18, 1998 | K980333 | RELIEFBAND Woodside Biomedical, Inc. | GZJ |
| Jan 23, 1998 | K974497 | INTELECT Chattanooga Group, Inc. | GZJ |
| Aug 27, 1997 | K965244 | Z TECH TRANSCUTANEOUS NEURAL STIMULATION Z Technologies, LLC | GZJ |
| Aug 6, 1997 | K962951 | MODEL HS-2 TENS DEVICE Technalithics Laboratories, Inc. | GZJ |
| Aug 1, 1997 | K965187 | SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD Sparta Surgical Corp. | GZJ |
| Aug 1, 1997 | K961050 | RELIEFBAND TENS UNIT (MODIFICATION) Maven Labs, Inc. | GZJ |
| Jun 20, 1997 | K940954 | SYNAPTIC 3000 The Synaptic Corp. | GZJ |
| Apr 29, 1997 | K970429 | BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T Apex Medical Corp., TW | GZJ |
| Apr 25, 1997 | K953982 | SIMPLEX TENS Armstrong Industries, Inc. | GZJ |
| Apr 14, 1997 | K970203 | EPIX VT Empi | GZJ |
| Mar 19, 1997 | K963507 | EXTRA TENS (RI-2500) NEO TENS (RI-2000E) Comtek Intl., Corp. | GZJ |
| Mar 18, 1997 | K970696 | S.P. 100 Lsi Intl., Inc. | GZJ |
| Feb 26, 1997 | K961809 | SHE-LI TENS STIMULATOR MODEL SL-101 RX Medi Consultants, Inc. | GZJ |
| Feb 13, 1997 | K963729 | SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD) Skylark Device Co., Ltd., TW | GZJ |
| Feb 6, 1997 | K963125 | M AND R REUSABLE ELECTRODES (MULTIPLE) M & R Mfg., Inc. | GZJ |
| Oct 22, 1996 | K955470 | ACTION POTENTIAL SIMULATION THERAPY DEVICE Neurotech, Inc. | GZJ |
| Sep 12, 1996 | K961376 | SMART-TENS, MODEL 456 Bio-Medical Research, Ltd. | GZJ |
| Sep 5, 1996 | K962910 | SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY Uni-Patch, Inc. | GZJ |
| Jul 31, 1996 | K962332 | TENS/FES/NMES ELECTRODES Uni-Patch, Inc. | GZJ |
| Jun 21, 1996 | K961749 | TRANSAMERICA ELECTRODE Transamerica Medical Systems | GZJ |
| May 30, 1996 | K954951 | TAYLOR GENERAL PURPOSE MONITORING ELECTRODE Taylor Industries, Inc. | GZJ |
| May 17, 1996 | K951951 | FOCUS MODEL 795 UNIT Empi | GZJ |
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