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 |
|---|---|---|---|
| Jun 22, 1990 | K900596 | ACUDATA INDICATENS MODEL 5A Acudata Software | GZJ |
| Apr 26, 1990 | K896620 | NEUROTENS Henley Intl. | GZJ |
| Apr 10, 1990 | K896226 | LISS BODY STIMULATOR MODEL SBL501-M Medical Consultants Intl. , Ltd. | GZJ |
| Feb 23, 1990 | K896948 | ALPHA-STIM CS Electromedical Products, Inc. | GZJ |
| Feb 2, 1990 | K883911 | ELECTRO-ACUSCOPE 85 Biomedical Design Instruments | GZJ |
| Jan 19, 1990 | K895289 | MEC-I-TRON MINI, MODEL M-2 Meyer Equipment Company, Inc. | GZJ |
| Jan 19, 1990 | K895183 | REBOX II (TENS) Rebox (Uk) , Ltd. | GZJ |
| Jan 9, 1990 | K895977 | ACUSOURCE 600 (TENS) Microcurrent Research, Inc. | GZJ |
| Jan 4, 1990 | K894964 | K-2 TENS OR MED TENS Oms Medical Supplies, Inc. | GZJ |
| Dec 8, 1989 | K895473 | DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S Medical Devices, Inc. | GZJ |
| Nov 6, 1989 | K895295 | ULTIMA XS MICROCURRENT TENS American Imex | GZJ |
| Oct 30, 1989 | K895334 | TTS2600 Henley Intl. | GZJ |
| Oct 30, 1989 | K895211 | TTS2700 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR Henley Intl. | GZJ |
| Oct 30, 1989 | K895166 | TTS2500 Henley Intl. | GZJ |
| Oct 30, 1989 | K895161 | TTS2800 Henley Intl. | GZJ |
| Oct 24, 1989 | K883811 | ELECTRONIC PAIN RELIEVERS Jetco of America | GZJ |
| Oct 12, 1989 | K891992 | TENZCARE STIMULATOR 6890 3M Company | GZJ |
| Sep 7, 1989 | K890087 | ACUDATA INDICATENS MODEL 5M Acudata Software | GZJ |
| Sep 6, 1989 | K894127 | LUMISCOPE MODEL 1000/APCC MODEL 1000 Lumiscope Co., Inc. | GZJ |
| Sep 6, 1989 | K891118 | STERLING TENS Armstrong Industries, Inc. | GZJ |
| Aug 10, 1989 | K894388 | ZIMMER TENS American Imex | GZJ |
| Jul 27, 1989 | K884972 | TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR Futuremed Div. of Future Impex Corp. | GZJ |
| Jun 23, 1989 | K892408 | NSD 8CS8 - TENS DEVICE Future Medical Products, Inc. | GZJ |
| Jun 6, 1989 | K884869 | MODIFIED MRL NEUROPROBE SYSTEM V Medical Research Laboratories, Inc. | GZJ |
| Jun 1, 1989 | K890604 | EMPI, MODEL 489, TENS Empi | GZJ |
| May 26, 1989 | K890088 | ACUDATA INDICATENS MODEL 5X Acudata Software | GZJ |
| Apr 26, 1989 | K885190 | MICRO-STIM 200 Theri-Teck, Inc. | GZJ |
| Apr 24, 1989 | K882980 | REBUILDER BUCKET SYSTEM Micromed, Inc. | GZJ |
| Mar 9, 1989 | K890705 | MEDIMOD(TM), MODEL 8900 Medical Devices, Inc. | GZJ |
| Feb 13, 1989 | K884833 | ULTRA 2000 (T.E.N.S.) Maxima Intl., Inc. | GZJ |
| Feb 9, 1989 | K880744 | ANESTY 10 Nihon Medix Co., Ltd. | GZJ |
| Dec 16, 1988 | K883188 | T.E.N.S. UNIT SIGMA & TX-3 Diamond Medical Equipment, Inc. | GZJ |
| Dec 12, 1988 | K884210 | TX-7 (TENS) (IC-1107) Oms Medical Supplies, Inc. | GZJ |
| Nov 16, 1988 | K883236 | CEFAR DUAL Cefar Medical Products, Inc. | GZJ |
| Oct 13, 1988 | K884032 | MORGAN TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR Morgan Associates, Inc. | GZJ |
| Sep 30, 1988 | K882154 | HEPAX (TENS) Avl Scientific Corp. | GZJ |
| Sep 28, 1988 | K874818 | TENSTAR Healthcheck Corp. | GZJ |
| Sep 22, 1988 | K882631 | EMPI MODEL 727,NMS Empi | GZJ |
| Sep 22, 1988 | K875072 | MODIFIED AMANA ELECTROTHERAPEUTIC SYSTEM Amana Medical Group | GZJ |
| Sep 19, 1988 | K880426 | ELECTROSTIMULATOR MODEL 808 Cornell Enterprises Co., Inc. | GZJ |
| Aug 30, 1988 | K881753 | ALPHA-STIM 350 Electromedical Products, Inc. | GZJ |
| Aug 29, 1988 | K882820 | MEDIPAC II EC (TM), MODEL 7900 Medical Devices, Inc. | GZJ |
| Aug 19, 1988 | K882943 | MEDA ONE-STEP Medical Electronic Assn. | GZJ |
| Aug 11, 1988 | K881708 | INDICATENS 4X4 Acudata Software | GZJ |
| Aug 1, 1988 | K880042 | ACUTRON Davis Assoc. | GZJ |
| Jul 1, 1988 | K881832 | DS-200 AND DS-400 T.E.N.S. Delta Marketing, Inc. | GZJ |
| May 4, 1988 | K881704 | EASY TENS American Imex | GZJ |
| Apr 18, 1988 | K880492 | INTERCEPT T.E.N.S. DEVICE Medical Design & Manufacturing Corp. | GZJ |
| Apr 15, 1988 | K881114 | EMPI MODEL 989, TENS Empi | GZJ |
| Apr 11, 1988 | K881424 | PREMIER 10S (TENS) American Imex | GZJ |
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