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 |
|---|---|---|---|
| Mar 20, 2003 | K030537 | DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B Well-Life Healthcare, Inc., TW | GZJ |
| Mar 18, 2003 | K030140 | DUOMED, SERIES 500, (MODELS ID 500, FL 500) Duomed, Inc. | GZJ |
| Feb 6, 2003 | K021271 | ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-3 Biomedical Life Systems | GZJ |
| Feb 6, 2003 | K021270 | ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-2 Biomedical Life Systems | GZJ |
| Jan 13, 2003 | K023443 | MEDS-3 NEUROMUSCULAR STIMULATOR Medical Equipment Device Specialists | GZJ |
| Jan 13, 2003 | K023435 | MEDS-4 NEUROMUSCULAR STIMULATOR Medical Equipment Device Specialists | GZJ |
| Jan 13, 2003 | K021794 | TATUNG TMD-26AX SERIES TENS, MODELS NO. TMD-26AB TATUNG TENS (BLUE HOUSING) TMD-26AY TATUNG TENS (YELLOW HOUSING) Tatung Co. | GZJ |
| Dec 30, 2002 | K020020 | THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302) Well-Life Healthcare, Inc., TW | GZJ |
| Dec 2, 2002 | K021430 | SANIDAD TENS-DUO MODE GP8016N Rolor Electronics Corp., TW | GZJ |
| Nov 22, 2002 | K021846 | 804SIII; 804W; LIBRA TENS; 410; S-TENS II Body Clock Health Care, Ltd., GB | GZJ |
| Nov 19, 2002 | K022925 | ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10 Biomedical Life Systems, Inc. | GZJ |
| Nov 19, 2002 | K022841 | ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9 Biomedical Life Systems, Inc. | GZJ |
| Nov 14, 2002 | K022731 | V TENS PLUS Body Clock Health Care, Ltd., GB | GZJ |
| Oct 31, 2002 | K020749 | DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS Everyway Medical Instruments Co.,Ltd | GZJ |
| Sep 24, 2002 | K022076 | FIRST CHOICE & FIRST CHOICE PLUS Body Clock Health Care, Ltd., GB | GZJ |
| Sep 24, 2002 | K020712 | ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4 Biomedical Life Systems, Inc. | GZJ |
| Aug 22, 2002 | K013532 | ULTRASTIM KIT Axelgaard Mfg. Co., Ltd. | GZJ |
| Aug 12, 2002 | K022405 | MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MIC Rehabilicare, Inc. | GZJ |
| Aug 6, 2002 | K021496 | HMS-DHR-3 NEUROMUSCULAR STIMULATOR Home Medical Services | GZJ |
| Jul 30, 2002 | K021436 | TTECH MODEL 200E + TENS DEVICE Theratech, Inc. | GZJ |
| Jul 30, 2002 | K011891 | PANAG Panag International, ZA | GZJ |
| Jul 11, 2002 | K014020 | NT MEDITENS PLUS, TYPE 290 Bio-Medical Research, Ltd., IE | GZJ |
| Jun 12, 2002 | K021755 | APEX MEDICAL DIGITAL TENS TS1211, TS1212 Apex Medical Corp., TW | GZJ |
| Jun 10, 2002 | K020803 | CEFAR MEDICAL AB CEFAR PRIMO Cefar Medical AB | GZJ |
| May 21, 2002 | K020846 | ULTIMA TENS XL-A1 Tenscare, Ltd., GB | GZJ |
| May 3, 2002 | K014126 | SANIDAD HEALTH-UP TENS MP-73725 Roc Chinese-European Industrial Research Society, TW | GZJ |
| Apr 30, 2002 | K021359 | DIGI-PRO TENS MODEL WL-2203 AND WL-2205 Well-Life Healthcare, Inc., TW | GZJ |
| Apr 4, 2002 | K013210 | TRUWAVE Dan Med, Inc. | GZJ |
| Mar 21, 2002 | K020180 | RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL Woodside Biomedical, Inc. | GZJ |
| Mar 15, 2002 | K020437 | CLASSIC TENS Care Rehab, Inc. | GZJ |
| Feb 20, 2002 | K003744 | ENRAF-NONIUS ENDOMED 182 SYSTEM Henley Healthcare, Inc. | GZJ |
| Jan 31, 2002 | K020032 | APEX MEDICAL MINI TENS Apex Medical Corp., TW | GZJ |
| Jan 30, 2002 | K013167 | MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500 Newcare Products, LLC | GZJ |
| Jan 25, 2002 | K013507 | COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH Cosmo Health, Inc. | GZJ |
| Dec 13, 2001 | K004008 | STRESS GUARD, MODEL HERDEV1 Herbo Medex International, Inc. | GZJ |
| Oct 29, 2001 | K012643 | APEX MEDICAL LCD TENS-VII Apex Medical Corp., TW | GZJ |
| Oct 25, 2001 | K012848 | WINNER CM4 COMBINATION UNIT Rich-Mar Corp. | GZJ |
| Oct 12, 2001 | K010615 | CYCLOTEC AMT CTI TENS DEVICE Cyclotec | GZJ |
| Sep 24, 2001 | K011017 | PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT Rehabilicare, Inc. | GZJ |
| Aug 31, 2001 | K011543 | TENS CARE, MODEL XL-Y3 Tenscare, Ltd., GB | GZJ |
| Aug 28, 2001 | K010203 | ACCU-PULSE TENS UNIT Sadler Electronics, ZA | GZJ |
| Aug 3, 2001 | K010295 | MICROSTIM 100I TENS DEVICE Microstim, Inc. | GZJ |
| Jul 27, 2001 | K002874 | WELL-TENS Well-Life Consultant, TW | GZJ |
| Jun 12, 2001 | K010209 | ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL Biomedical Life Systems, Inc. | GZJ |
| Jun 12, 2001 | K001897 | MULTI-STIM, MODEL MS-100 Metron Medical Australia, Pty, Ltd., AU | GZJ |
| Apr 27, 2001 | K010782 | TRANSAMERICAN TENS Transamerica Medical Systems | GZJ |
| Mar 15, 2001 | K002297 | YORAMED, MODEL T-202 United Yoram Distributors, Inc. | GZJ |
| Mar 8, 2001 | K003369 | LIFECARE COMPACT TENS DEVICE Lifecare , Ltd., IL | GZJ |
| Feb 21, 2001 | K003507 | MEDRELIEF Healthonics, Inc. | GZJ |
| Feb 14, 2001 | K003591 | TENSCARE, MODEL TENS XL-2 Tenscare, Ltd., GB | GZJ |
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