Panels › Physical Medicine › Product code IKN · Class 2
Electromyograph, Diagnostic
Regulation 890.1375
0510(k)s in 12 months (75 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in IKN
| Company | 510(k)s | Recalls |
|---|---|---|
| Nicolet Biomedical Instruments | 6 | 0 |
| Fasstech | 3 | 0 |
| Teca, Inc. | 3 | 0 |
| Aaron Laboratories, Inc. | 2 | 0 |
| Advantage Medical Division of Cme Telemetrix | 2 | 0 |
| Bio-Logic Systems Corp. | 2 | 0 |
| Cadwell Laboratories, Inc. | 2 | 0 |
| Dorsavi, Ltd. | 2 | 0 |
| Excel Tech. , Ltd. | 2 | 0 |
| Life-Tech Instruments, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 19, 2017 | K172743 | Natus VikingQuest Natus Neurology Incorporated | IKN |
| Jul 14, 2017 | K163150 | ViMove2 Dorsavi, Ltd., AU | IKN |
| Mar 1, 2017 | K162383 | Cadwell Sierra Summit, Cadwell Sierra Ascent Cadwell Industries, Inc. | IKN |
| May 28, 2015 | K142494 | ViMove Dorsavi, Ltd., AU | IKN |
| Jul 11, 2014 | K131094 | VIMOVE Dorsa VI Pty., Ltd. | IKN |
| Sep 13, 2013 | K123902 | PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) Oktx, LLC | IKN |
| Aug 1, 2013 | K123399 | MYOVISION 3.0 WIREFREE SYSTEM Precision Biometrics, Inc. | IKN |
| Feb 2, 2012 | K113074 | CMAP PRO Medical Technologies, Inc. | IKN |
| Mar 4, 2011 | K102610 | FOCUS EMG DEVICE Teleemg, LLC USA | IKN |
| Jan 26, 2011 | K110048 | CERSR ELECTROMYOGRAPHY SYSTEM Spinematrix, Inc. | IKN |
| Sep 11, 2009 | K083679 | UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 Uroval | IKN |
| May 23, 2008 | K073415 | NEMUS SYSTEM; NEMUS PC PERIPHERAL Eb Neuro S.P.A. | IKN |
| Aug 16, 2007 | K063447 | INSIGHT DISCOVERY Fasstech | IKN |
| Oct 28, 2005 | K052112 | XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 Excel Tech. , Ltd., CA | IKN |
| Jan 7, 2004 | K031995 | COMPREHENSIVE NEUROMUSCULAR PROFILER Medical Technologies Unlimited, Inc. | IKN |
| Nov 28, 2003 | K033452 | CWAS 1000 Fasstech | IKN |
| Oct 10, 2003 | K023209 | INSIGHT MILLENNIUM III Fasstech | IKN |
| Jan 6, 2003 | K024316 | NIM-PRS Medtronic Xomed, Inc. | IKN |
| Dec 12, 2002 | K023147 | ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4 Bortec Biomedical, Ltd. | IKN |
| Nov 13, 2002 | K022719 | PHYSICAL MONITORING REGISTRATION UNIT Maryrose Cusimano, Ph.D./Phil Reaston | IKN |
| Jun 28, 2001 | K010590 | NEUROPACK MICRO, MODEL MED-9100A SERIES Nihon Kohden America, Inc. | IKN |
| Oct 10, 2000 | K002104 | COMBINED PHYSIOLOGICAL MONITORING SYSTEM Maryrose Cusimano, Ph.D. & Scott Zeff | IKN |
| Sep 12, 2000 | K001800 | ACCUWARM EMG HEAT LAMP Rjl Associates, LLC | IKN |
| Aug 16, 2000 | K001562 | NEURO SCAN MEDICAL SYSTEMS A4000 Neuro Scan Labs | IKN |
| May 17, 2000 | K000812 | NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE) Neurosoft, Inc. | IKN |
| Feb 24, 2000 | K000220 | MA-300 ELECTROMYOGRAPHY SYSTEM Motion Lab Systems, Inc. | IKN |
| Feb 1, 2000 | K993878 | JE 2000 Jack'S Electrodes | IKN |
| Aug 27, 1999 | K990766 | CERSR ELECTROMYOGRAPHY SYSTEM Paraspinal Diagnostic Corp. | IKN |
| May 17, 1999 | K984052 | SYNERGY IOM SYSTEM Oxford Instruments Medical Systems | IKN |
| Apr 30, 1998 | K972419 | TOENNIES NEUROSCREEN SYSTEM Erich Jaeger, Inc., DE | IKN |
| Feb 19, 1998 | K974385 | MLS ELECTROMYOGRAPHIC PREAMPLIFIER Motion Lab Systems, Inc. | IKN |
| Jan 16, 1998 | K974010 | ADVANTAGE EMG SYSTEM, MODEL #A100 Advantage Medical Division of Cme Telemetrix, CA | IKN |
| Dec 5, 1997 | K973355 | ADVANTAGE 3000 Advantage Medical Division of Cme Telemetrix, CA | IKN |
| Nov 7, 1995 | K941144 | EXCEL EMG Excel Tech. , Ltd., CA | IKN |
| Oct 7, 1995 | K942965 | COMPUTER DYNO/GONIO/MYO GRAPHY Infotronic Medical Engineering | IKN |
| Sep 28, 1995 | K952655 | B & L ELECTRODE B & L Engineering | IKN |
| Jul 7, 1995 | K944787 | INTEGRATED MOVEMENT ANALYZER Maryrose | IKN |
| May 1, 1995 | K935368 | STC DIAGNOSTIC 8000 Sherman Technology Corp. | IKN |
| Jul 2, 1993 | K930328 | NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT Bio-Logic Systems Corp. | IKN |
| Mar 2, 1993 | K922488 | PHASIS ELECTROMYOGRAPH Biosound, Inc. | IKN |
| Dec 4, 1991 | K911388 | CAVOMAT Wiest USA, Inc. | IKN |
| Sep 10, 1991 | K901732 | EMG ACCESSORY FOR POSTUROGRAPHY Neurocom International, Inc. | IKN |
| Jul 9, 1991 | K912071 | SPACE(TM) 7500 F.M. Wiest USA, Inc. | IKN |
| Mar 20, 1990 | K893130 | EMG NAVIGATOR & EMG TRAVELER Bio-Logic Systems Corp. | IKN |
| Jun 5, 1989 | K883781 | NICOLET NEUROPORT/ACE SYSTEM Nicolet Instrument Corp. | IKN |
| Mar 16, 1989 | K890495 | NICOLET VIKING II SYSTEM Nicolet Instrument Corp. | IKN |
| Apr 13, 1988 | K880977 | ADR-2000 AMBULATORY DATA RECORDING SYSTEM Aaron Laboratories, Inc. | IKN |
| Apr 13, 1988 | K880976 | AL-200B MUSCLE ACTIVITY INTEGRATOR Aaron Laboratories, Inc. | IKN |
| Mar 22, 1988 | K880573 | MODIFIED NICOLET VIKING SYSTEM Nicolet Biomedical Instruments | IKN |
| Sep 29, 1987 | K872836 | SPINOSCOPE Diagnospine Fabrication, Inc., CA | IKN |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.