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 |
|---|---|---|---|
| Aug 14, 1992 | K921110 | TENS Staodyne, Inc. | GZJ |
| May 4, 1992 | K915210 | ELECTRO-NERVE STIMULATOR TENS MODEL MICRO PLUS-A Biomedical Life Systems, Inc. | GZJ |
| Jan 30, 1992 | K912381 | LOW BACK STRIP (OR) K-BACK Katecho, Inc. | GZJ |
| Jan 17, 1992 | K910727 | EXCEL MODEL 2110 Excel Medical Systems, Inc. | GZJ |
| Dec 31, 1991 | K914813 | THERASTIM Precision Electronics , Ltd. | GZJ |
| Dec 18, 1991 | K914871 | TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL Labeltape Meditect, Inc. | GZJ |
| Dec 17, 1991 | K914441 | MENS 2000-D Monad Corp. | GZJ |
| Dec 10, 1991 | K911963 | MEDTRONIC MODEL 90002065 MF TENS SYSTEM Medtronic Vascular | GZJ |
| Nov 22, 1991 | K913532 | TX 3 TENS MODIFIED Globalcare/Bay Medical Corp. | GZJ |
| Nov 22, 1991 | K912289 | ULTIMA XS, MODIFICATION American Imex | GZJ |
| Nov 19, 1991 | K901704 | RELIEF BAND (T.E.N.S. DEVICE) Maven Labs, Inc. | GZJ |
| Nov 13, 1991 | K912463 | MICRO-Q Quantitative Medicine, Inc. | GZJ |
| Nov 13, 1991 | K912460 | Q-TENS Quantitative Medicine, Inc. | GZJ |
| Oct 25, 1991 | K912178 | BIO TENS 601, 606 AND 608 (3000) Skylark Device Co., Ltd., TW | GZJ |
| Oct 15, 1991 | K911814 | AXION 5, MODIFICATION Ventura Medical Electronics | GZJ |
| Oct 15, 1991 | K905672 | TEAM-MC Henley Intl. | GZJ |
| Oct 4, 1991 | K913800 | MEDA CROWN SERIES Medical Electronic Assn. | GZJ |
| Aug 28, 1991 | K913522 | SOLITENS MODIFIED Innovative Designer Products, Inc. | GZJ |
| Aug 23, 1991 | K913594 | DYNEX IIIB, MODEL 89002026 Medtronic Vascular | GZJ |
| Jul 9, 1991 | K910244 | GLOBAL CARE MICRO II Globalcare Intl., Inc. | GZJ |
| Jun 24, 1991 | K912348 | SX90 (TM),MODEL 4800S Medical Devices, Inc. | GZJ |
| Jun 21, 1991 | K905526 | AGARRELIEF 10 TRANSCUTANEOUS ELEC NERVE STIMULATOR Agar Ginosar Electronics, IL | GZJ |
| Jun 20, 1991 | K910580 | MICROSTIM 100 MODEL 2C Microstim, Inc. | GZJ |
| Jun 6, 1991 | K902226 | MY-O-MATIC 5000I Monad Corp. | GZJ |
| Jun 4, 1991 | K905570 | ELECTRO-NERVE STIMULATOR TENS MODEL BIOMED 2000/A Biomedical Life Systems, Inc. | GZJ |
| Jun 4, 1991 | K905377 | ELECTRO-NERVE STIMULATOR TENS MODEL SYSTEMS 2000/A Biomedical Life Systems, Inc. | GZJ |
| Jun 4, 1991 | K905230 | ELECTRO-NEVE STIMULATOR TENS MODEL BIOMED PLUS/A Biomedical Life Systems, Inc. | GZJ |
| Jun 4, 1991 | K904388 | POINTER F-3 TENS Oms Medical Supplies, Inc. | GZJ |
| May 30, 1991 | K902102 | COM-TENS: A NEUROSTIMULATOR Apex Medical, Inc. | GZJ |
| May 13, 1991 | K904430 | MENS FREEDOM MICRO Monad Corp. | GZJ |
| May 13, 1991 | K904288 | MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS Monad Corp. | GZJ |
| May 13, 1991 | K904260 | MENS-O-MATIC 3000 Monad Corp. | GZJ |
| May 13, 1991 | K904258 | MICRO DERM Monad Corp. | GZJ |
| May 13, 1991 | K904235 | MENS-O-MATIC 2000 Monad Corp. | GZJ |
| May 13, 1991 | K904234 | MENS-O-MATIC I Monad Corp. | GZJ |
| May 9, 1991 | K904264 | MODEL SW-103 SOLITANS STIMULATOR Medical Consultants Intl. , Ltd. | GZJ |
| May 6, 1991 | K903394 | GLOBALCARE MICRO 11 AND MICROCARE (TENS) Globalcare Intl., Inc. | GZJ |
| Apr 3, 1991 | K904457 | DIAL-AWAY PAIN R.F.P., Inc. | GZJ |
| Mar 27, 1991 | K903161 | MC II (TM), MODEL 7200S Medical Devices, Inc. | GZJ |
| Mar 15, 1991 | K903577 | DYNATRON 200 MICROCURRENT Dynatronics Corp. | GZJ |
| Jan 18, 1991 | K903828 | SYNAPS (TM) Henley Intl. | GZJ |
| Jan 2, 1991 | K903128 | STIMTRAC PC, CATALOG NO. 78-8510 Stimtech Products | GZJ |
| Dec 19, 1990 | K902822 | MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE Medical Design & Manufacturing Corp. | GZJ |
| Nov 16, 1990 | K896825 | TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR Infrasonics Corp. | GZJ |
| Oct 26, 1990 | K903017 | MEGA-TENS DUAL CHANNEL T.E.N.S. Futuremed Div. of Future Impex Corp. | GZJ |
| Sep 20, 1990 | K896408 | QUANTUM Stressmaster Systems, Inc. | GZJ |
| Aug 28, 1990 | K901417 | ELECTROSTIM MST Promatek Industries, Ltd., CA | GZJ |
| Aug 14, 1990 | K901726 | LUMISCOPE MICRO 100 Lumiscope Co., Inc. | GZJ |
| Jul 30, 1990 | K896787 | TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION Saratoga Intl., Inc. | GZJ |
| Jun 22, 1990 | K900668 | ACUDATA INDICATENS MODEL 5XS Acudata Software | GZJ |
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