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 |
|---|---|---|---|
| Oct 13, 2006 | K060669 | MEDRELIEF ST SERIES, MODELS RT-50, ST-100, ST 150, ST-200, ST-300 Healthonics, Inc. | GZJ |
| Aug 28, 2006 | K061799 | QUADRATENS, MODEL QT-42 Bio-Research Associates, Inc. | GZJ |
| Jul 26, 2006 | K061476 | ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1 Biomedical Life Systems, Inc. | GZJ |
| Jun 23, 2006 | K052711 | EMJOI TENS DEVICE Emjoi, Inc. | GZJ |
| Jun 19, 2006 | K060517 | POINTER EXCEL Lhasa Oms, Inc. | GZJ |
| Jun 19, 2006 | K060508 | POINTER PLUS Lhasa Oms, Inc. | GZJ |
| May 5, 2006 | K060246 | INFREX Johari Digital Healthcare , Ltd. | GZJ |
| Apr 6, 2006 | K050989 | AWQ-104 Lhasa Oms, Inc. | GZJ |
| Mar 14, 2006 | K060368 | INSPIRSTAR IS02 MICROCURRENT STIMULATOR Inspirstar, Inc. | GZJ |
| Mar 10, 2006 | K053284 | MAGBODY DT-600 Durtech System Corp., TW | GZJ |
| Mar 10, 2006 | K051128 | ELECTROPULSE Pain Relief Technologies | GZJ |
| Feb 24, 2006 | K051020 | ES-160 Lhasa Oms, Inc. | GZJ |
| Jan 25, 2006 | K052813 | FD TENS 2030, MODEL DFJ24T Fuji Dynamics Limited, HK | GZJ |
| Nov 4, 2005 | K052182 | SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S. Shian Jia Meei Enterprise Co., Ltd. | GZJ |
| Sep 7, 2005 | K050174 | BIO-STIM KIT Skylark Device & Systems Co., Ltd., TW | GZJ |
| Sep 6, 2005 | K050435 | E-STIM II Lhasa Oms, Inc. | GZJ |
| May 17, 2005 | K042912 | INTERX5000 Neuro Resource Group, Inc. | GZJ |
| Apr 6, 2005 | K050740 | MICROWARE 200 Microware, Inc. | GZJ |
| Mar 14, 2005 | K042711 | MODEL BMLS03-7 Biomedical Life Systems, Inc. | GZJ |
| Mar 9, 2005 | K042107 | TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001 Tung FU Electric Co., Ltd., TW | GZJ |
| Nov 23, 2004 | K041388 | COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1 Biomedical Life Systems, Inc. | GZJ |
| Nov 18, 2004 | K041172 | BASBA E-MACHINE Basba, Inc. | GZJ |
| Nov 17, 2004 | K042559 | GEM-TWIN TENS/ MODELS GM3XY/Z Gemore Technology Co, Ltd., TW | GZJ |
| Oct 1, 2004 | K040311 | SHIAN JIA MEEI DIGATAL PWN TENS, MODEL YW-6000/UC-332/UC-330/ST-331 Shian Jia Meei Enterprise Co., Ltd. | GZJ |
| Sep 3, 2004 | K041520 | MANTRA TENS MODEL NT3 Mantra Intl. (Hk) , Ltd. | GZJ |
| Aug 20, 2004 | K041359 | BODY CLOCK STIMPLUS AND STIMPLUS PRO Body Clock Health Care, Ltd., GB | GZJ |
| Jul 16, 2004 | K041575 | FENZIAN TREATMENT SYSTEM Eumedic Limited | GZJ |
| Jul 1, 2004 | K041092 | FAST START TENS, MODEL FS 3001 Vision Quest Industries, Inc. | GZJ |
| May 27, 2004 | K040512 | LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401 Well-Life Healthcare, Inc. | GZJ |
| May 20, 2004 | K041164 | L-TENS Fuji Dynamics Limited, CN | GZJ |
| Apr 27, 2004 | K040193 | MODEL GST-1 Medical Equipment Device Specialists | GZJ |
| Apr 15, 2004 | K023916 | BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294 Bio-Medical Research, Ltd., IE | GZJ |
| Apr 8, 2004 | K040253 | EASY MED TN-28 C Easy Med Instrument Co., Ltd., CN | GZJ |
| Jan 15, 2004 | K033455 | ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 Biomedical Life Systems, Inc. | GZJ |
| Jan 7, 2004 | K032003 | PREMIER PLUS American Imex | GZJ |
| Dec 19, 2003 | K033857 | T-TECH DIGITAL, MODEL WL-22XXA SERIES Well-Life Healthcare, Inc., TW | GZJ |
| Dec 19, 2003 | K032928 | MEDIPHYSICS PAIN TREATMENT SYSTEM, MODEL 1 Mediphysics Pain Centers of America | GZJ |
| Dec 16, 2003 | K032994 | GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING) Gemore Technology Co, Ltd., TW | GZJ |
| Dec 10, 2003 | K032720 | GEM-STIM TENS, MODELS GM3XY AND GM3AXY Gemore Technology Co, Ltd., TW | GZJ |
| Nov 28, 2003 | K031374 | BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 Besmed Health Business Corp, TW | GZJ |
| Nov 13, 2003 | K031546 | RAINBOW GT-4A PAIN RELIEF MACHINE Sino-Us Information, Inc. | GZJ |
| Oct 21, 2003 | K033253 | S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR Micro Current Technology, Inc. | GZJ |
| Oct 3, 2003 | K032055 | MEDS-4-INF+ Medical Equipment Device Specialists | GZJ |
| Sep 12, 2003 | K032653 | E275 Micro Current Technology, Inc. | GZJ |
| Aug 25, 2003 | K023913 | NEUROTECH BAXOLVE TYPE 294 Bio-Medical Research, Ltd., IE | GZJ |
| Jun 17, 2003 | K023726 | TENS PRO 900 Acumed Medical Supplies , Ltd. | GZJ |
| May 20, 2003 | K022849 | BODY CLOCK TENS N' TONE Body Clock Health Care, Ltd., GB | GZJ |
| May 2, 2003 | K021952 | HIVOX DREAMATE DM-800 Hivox Biotek, Inc., TW | GZJ |
| Apr 10, 2003 | K022417 | CARE STIM Care Rehab and Orthopaedic | GZJ |
| Apr 4, 2003 | K023231 | ELFCARE DEVICE, MODELS 314A THROUGH 314G Mediseb , Ltd., IL | GZJ |
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