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 18, 1986 | K853898 | SKYLARK MODEL 1001 TENS DEVICE Peleg Intl. Co., CA | GZJ |
| May 16, 1986 | K861709 | A TENS (MODEL AI-86) American Imex | GZJ |
| May 9, 1986 | K860772 | HARIKY, MODEL GK-7 K-Mot, Inc. | GZJ |
| May 8, 1986 | K861501 | EXER-STIM 2 Th Charters, Inc. | GZJ |
| Feb 28, 1986 | K854316 | FASTENS(TM) Medical Devices, Inc. | GZJ |
| Feb 27, 1986 | K854476 | KALMATE MODEL 3A Medical Technology Systems, Inc. | GZJ |
| Feb 21, 1986 | K853992 | VALLEY FORGE SCIEN-TENS UNIT & ACCESS. LEAD WIRE & Valley Forge Scientific Corp. | GZJ |
| Feb 14, 1986 | K854761 | MINIPAC PERSONAL TOUCH (TM) Medical Devices, Inc. | GZJ |
| Jan 30, 1986 | K853885 | MODEL RF-TENS-4 TRANSCUTANEOUS ELEC. NERVE STIMULA Uniking Intl. Corp. | GZJ |
| Jan 21, 1986 | K854317 | MINIPAC (TM) Medical Devices, Inc. | GZJ |
| Jan 9, 1986 | K850855 | TENS GB1001 DEVICE Medicon, Inc. | GZJ |
| Dec 9, 1985 | K853836 | NEURO PULSE II Nagata Engineering Co. | GZJ |
| Dec 9, 1985 | K853442 | MODEL 804 (TENS) Oriental Medical Supplies, Inc. | GZJ |
| Dec 4, 1985 | K853719 | TRANSCUTANEOUS ELECT. NERVE STIMUL-MYOSTIM 410 Electro Therapeutic Devices, Inc., CA | GZJ |
| Dec 4, 1985 | K853718 | TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804 Electro Therapeutic Devices, Inc., CA | GZJ |
| Nov 19, 1985 | K851735 | SYS STIM 206 MODEL ME206 Mettler Electronics Corp. | GZJ |
| Nov 7, 1985 | K853416 | MES-TENS(TENS) Oriental Medical Supplies, Inc. | GZJ |
| Aug 28, 1985 | K852838 | ADVANCED MEDICAL PRODUCTS MES TENS Advanced Medical Products, Inc. | GZJ |
| Aug 28, 1985 | K852837 | ADVANCED MEDICAL PRODUCTS DR PULSE (TENS) Advanced Medical Products, Inc. | GZJ |
| Aug 28, 1985 | K852836 | ADVANCED MEDICAL PRODUCTS MINI-M (TENS) Advanced Medical Products, Inc. | GZJ |
| Aug 21, 1985 | K844618 | BIO-TENS Bio-Research Associates, Inc. | GZJ |
| Jul 1, 1985 | K851511 | ACCURATECARE I & ACCURATECARE II Sunnex, Inc. | GZJ |
| Jun 4, 1985 | K851063 | TENSMED II Intermedics, Inc. | GZJ |
| May 31, 1985 | K851191 | ELECTRO-NERVE STIMULATOR DISCO B9 TENS Biomedical Life Systems, Inc. | GZJ |
| May 31, 1985 | K850860 | AXON II BRAND OF DUAL CHANNEL TENS Cassandra Electronics Corp. | GZJ |
| May 23, 1985 | K851185 | ELECTRO-NERVE STIMULATOR B4/B400 Biomedical Life Systems, Inc. | GZJ |
| Apr 5, 1985 | K844680 | CYBERTENS Pori Associates, Inc. | GZJ |
| Apr 2, 1985 | K850004 | TRANSCUTANEOUS NERVE STIMULATOR FOR PAIN RELIEF Todd Medical, Inc. | GZJ |
| Mar 6, 1985 | K844994 | THE MEHESZ STIMULATING SYSTEM Campden Medical , Ltd., GB | GZJ |
| Mar 5, 1985 | K841427 | ACCU-O-MATIC Myomed, Inc. | GZJ |
| Jan 24, 1985 | K844279 | INTERCEPTOR, 662-01 Intermedics, Inc. | GZJ |
| Jan 23, 1985 | K844076 | ELECTRO-NERVE STIMULATOR B5/SK700B Biomedical Life Systems, Inc. | GZJ |
| Jan 14, 1985 | K842888 | DUAL CHANNEL TENS, PULSAR REMOTE CONTRL Cryomedics, Inc. | GZJ |
| Jan 10, 1985 | K844213 | STIMTECH SD PATIENT 6089 #78-8050 Codman & Shurtleff, Inc. | GZJ |
| Jan 10, 1985 | K844212 | STIMTECH SD CLINICIAN 6090 #78-8055 Codman & Shurtleff, Inc. | GZJ |
| Jan 8, 1985 | K844638 | ELECTROCAINE MODEL SR-IV Electrocaine Medical System | GZJ |
| Nov 29, 1984 | K843637 | HEALTH PULSE FA-222 TRANSCUTANEOUS ELEC. NERVE STI Therapeutic Equipment Corp. | GZJ |
| Nov 28, 1984 | K840099 | MODEL 800-A VERI/PPR Verite | GZJ |
| Oct 22, 1984 | K843822 | MEA110 Canadian Medical Products, CA | GZJ |
| Oct 12, 1984 | K843793 | A-T TENS BELT A-T Surgical Mfg. Co., Inc. | GZJ |
| Oct 4, 1984 | K841184 | ELECTRO-NERVE STIMULATOR HL Biomedical Life Systems, Inc. | GZJ |
| Aug 17, 1984 | K843119 | ETI TENS BELT Electro Therapeutic Devices, Inc. | GZJ |
| Aug 8, 1984 | K842812 | MENTOR 150 PLUS TRANSCUTANEOUS ELEC. Mentor Corp. | GZJ |
| Jul 27, 1984 | K842414 | ECHO PULSE BURST Rabar, Inc. | GZJ |
| Jul 17, 1984 | K840098 | MODEL 811 VERI/TENS & PO Verite | GZJ |
| Jun 15, 1984 | K841400 | NEURO PULSE Parker Laboratories, Inc. | GZJ |
| Apr 23, 1984 | K840964 | SD PLUS CLINICIAN CAT# 78-8015 Codman & Shurtleff, Inc. | GZJ |
| Apr 23, 1984 | K840963 | SD PLUS PATIENT CAT.#78-8010 Codman & Shurtleff, Inc. | GZJ |
| Apr 16, 1984 | K840497 | OBSTETRIC PULSAR TWO CHANNEL TENS Spembly Medical , Ltd. | GZJ |
| Apr 13, 1984 | K841045 | EMPI MODEL 984 BASIX, TENS Empi | GZJ |
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