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 |
|---|---|---|---|
| Feb 10, 1982 | K813283 | 10D (TENS DEVICE) Staodynamics, Inc. | GZJ |
| Dec 29, 1981 | K813501 | TRANSCUTANEOUS ELEC. NERVE STIMULATOR Empi | GZJ |
| Nov 27, 1981 | K813100 | BIO-STIMULATOR, MODEL 400 Med-Western Electronics, Inc. | GZJ |
| Nov 6, 1981 | K812432 | HEALTH-UP Wfx Industries, Inc. | GZJ |
| Oct 19, 1981 | K812704 | NEUROMED SELECTRA #7720 Medtronic Vascular | GZJ |
| Aug 20, 1981 | K812138 | TENS DEVICE Western Advanced Technology, Inc. | GZJ |
| Aug 20, 1981 | K811499 | TENSMAX Anritsu America Co. | GZJ |
| Aug 7, 1981 | K812036 | NEUROGAR III Inter Med Industries, Inc. | GZJ |
| Jul 30, 1981 | K811351 | VERI-FIER Verite | GZJ |
| Jul 23, 1981 | K811939 | VITATRON 88 Vitatronics | GZJ |
| Jul 10, 1981 | K811345 | INSIGHT Staodynamics, Inc. | GZJ |
| Jul 1, 1981 | K811095 | TRANSCUTANEOUS ELECTRICAL NERVE Acutec Corporation, Inc. | GZJ |
| Jun 12, 1981 | K810841 | MEDAID C.V.I., Inc. | GZJ |
| Jun 2, 1981 | K811224 | MINISTIM Medical Design & Manufacturing Corp. | GZJ |
| Jun 1, 1981 | K811012 | TENS-O-MATIC O-Matic, Inc. | GZJ |
| Mar 13, 1981 | K810593 | NEUROPAC ULTRA I Medical Devices, Inc. | GZJ |
| Dec 30, 1980 | K803121 | MENTOR 150 TRANSCUTANEOUS NERVE STIMULA George H. Frisch | GZJ |
| Dec 30, 1980 | K803113 | MENTOR 402 TRANSCUTANEOUS ELEC. STIMULAT George H. Frisch | GZJ |
| Dec 10, 1980 | K802779 | LOAD SENTINEL II, TRANS. ELEC. NERVE Powers Medical Systmes | GZJ |
| Dec 10, 1980 | K802678 | TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR General Medical Industries, Inc. | GZJ |
| Dec 1, 1980 | K802507 | TENSMATE EMPIMODEL 9980 Empi | GZJ |
| Oct 3, 1980 | K802063 | SPEMBLY 9000 & 9300 Spembly Medical , Ltd. | GZJ |
| Sep 26, 1980 | K802227 | ANASTIM II TRANSCUTANEOUS ELECTRICAL Biostim, Inc. | GZJ |
| Aug 20, 1980 | K801459 | ELECTRO-ACUSCOPE-70 Nebrensky Corp. | GZJ |
| Aug 14, 1980 | K801576 | NEUROGAR III-TRANSCUT. ELEC. NERVE STIM Inter Med Industries, Inc. | GZJ |
| May 23, 1980 | K800576 | CYCLOPAC CP100 TENS BANDAGE Cyclotechnical Medical Indust., Inc. | GZJ |
| May 14, 1980 | K801112 | EMPI MODEL 910S, TENS Empi | GZJ |
| Apr 10, 1980 | K800758 | TENZCARE DUAL-CHANNEL STIMULATOR 3M Company | GZJ |
| Apr 2, 1980 | K800630 | TYPE 4000 TRANSCUTANEOUS ELEC. STIM. Frye Electronics, Inc. | GZJ |
| Dec 20, 1979 | K792473 | THERAPETTE, MODEL NO MH-100 Technical Resources, Inc. | GZJ |
| Dec 18, 1979 | K792502 | TENS 4100 Staodynamics, Inc. | GZJ |
| Dec 13, 1979 | K792522 | MODEL 980D TENS NEUROPACER Empi | GZJ |
| Dec 13, 1979 | K792474 | TENS 4500 Staodynamics, Inc. | GZJ |
| Nov 21, 1979 | K792311 | MEDTRONIC MODEL 7728 NEUROMOD Medtronic Vascular | GZJ |
| Oct 2, 1979 | K791834 | NURITE II VRM DUAL (ELEC. NERVE STIM.) Bio-Medical Systems Corp. | GZJ |
| Oct 2, 1979 | K791833 | NURITE II VRM SINGLE (ELEC. NERVE STIM) Bio-Medical Systems Corp. | GZJ |
| Aug 22, 1979 | K791187 | MODEL 810 VERI/TGS Verite | GZJ |
| Jul 3, 1979 | K791158 | STIMULATOR, ELECTRICAL NERVE Electreat, Inc. | GZJ |
| Mar 8, 1979 | K782164 | STIMULATOR, MODEL 1-600 ELECTRIC NERVR Ipco Corp. | GZJ |
| Mar 2, 1979 | K790011 | STIMULATOR, MENTOR 100 NERVE Mentor Corp. | GZJ |
| Feb 8, 1979 | K790189 | ELECTREAT MODEL 250 TRANSCUTANEOUS STIM Electreat, Inc. | GZJ |
| Jan 5, 1979 | K782127 | STIMULATOR, ELECTRICAL NERVE Somatronics, Inc. | GZJ |
| Dec 14, 1978 | K782075 | STIMULATOR, MODEL 7727 Medtronic Vascular | GZJ |
| Nov 22, 1978 | K781829 | NEUROPAC ULTRA II Medical Devices, Inc. | GZJ |
| Nov 7, 1978 | K781670 | STIMULATOR, E.S.I. NEURO Evolutionary Systems, Inc. | GZJ |
| Oct 13, 1978 | K781683 | NURITE II, SINGLE Bio-Medical Systems Corp. | GZJ |
| Oct 11, 1978 | K781565 | ELECTRICAL NERVE STIMULATOR MODEL 6035 Stimulation Technology, Inc. | GZJ |
| Sep 27, 1978 | K781277 | STIMULATOR, NERVE, TRANSCUTANEOUS Psitron | GZJ |
| May 31, 1978 | K780828 | NURITE II Bio-Medical Systems Corp. | GZJ |
| May 12, 1978 | K780698 | STIMULATORS, NERVE, ELECTRICAL Med General | GZJ |
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