Electromyograph, Diagnostic
FDA product code IKN · Class II (moderate risk) · 21 CFR 890.1375 · Physical Medicine
75510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Nicolet Biomedical Instruments 6
- Teca, Inc. 3
- Fasstech 3
- Life-Tech Instruments, Inc. 2
- Bio-Logic Systems Corp. 2
- Nicolet Instrument Corp. 2
- Aaron Laboratories, Inc. 2
- Excel Tech. , Ltd. 2
- Advantage Medical Division of Cme Telemetrix 2
- Motion Lab Systems, Inc. 2
- Dorsavi, Ltd. 2
- Nihon Kohden America, Inc. 2
- Cadwell Laboratories, Inc. 2
- Oxford Metrics, Inc. 1
- Motion Control, Inc. 1
- Chattanooga Group, Inc. 1
- Guardian Products Co., Inc. 1
- Natus Neurology Inc 1
- Datex Division Instrumentarium Corp. 1
- Disa Electronics 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172743 | Natus VikingQuestIKN · Special | Natus Neurology Incorporated | 12/19/2017SE |
| K163150 | ViMove2IKN · Special | Dorsavi, Ltd. | 07/14/2017SE |
| K162383 | Cadwell Sierra Summit, Cadwell Sierra AscentIKN · Traditional | Cadwell Industries, Inc. | 03/01/2017SE |
| K142494 | ViMoveIKN · Traditional | Dorsavi, Ltd. | 05/28/2015SE |
| K131094 | VimoveIKN · Traditional | Dorsa VI Pty., Ltd. | 07/11/2014SE |
| K123902 | Physical Monitoring Registration Unit-S (Pmru-S)IKN · Traditional | Oktx, LLC | 09/13/2013SE |
| K123399 | Myovision 3.0 Wirefree SystemIKN · Traditional | Precision Biometrics, Inc. | 08/01/2013SE |
| K113074 | Cmap ProIKN · Traditional | Medical Technologies, Inc. | 02/02/2012SE |
| K102610 | Focus Emg DeviceIKN · Traditional | Teleemg, LLC USA | 03/04/2011SE |
| K110048 | Cersr Electromyography SystemIKN · Special | Spinematrix, Inc. | 01/26/2011SE |
| K083679 | Uroval BRS System, Model BRS01; Telesis, Model PROMO1IKN · Traditional | Uroval | 09/11/2009SE |
| K073415 | Nemus System; Nemus PC PeripheralIKN · Traditional | Eb Neuro S.P.A. | 05/23/2008SE |
| K063447 | Insight DiscoveryIKN · Traditional | Fasstech | 08/16/2007SE |
| K052112 | Xltek Xcalibur Emg / LT, Model PK1P33, PK1059IKN · Special | Excel Tech. , Ltd. | 10/28/2005SE |
| K031995 | Comprehensive Neuromuscular ProfilerIKN · Traditional | Medical Technologies Unlimited, Inc. | 01/07/2004SE |
| K033452 | Cwas 1000IKN · Traditional | Fasstech | 11/28/2003SE |
| K023209 | Insight Millennium IIIIKN · Traditional | Fasstech | 10/10/2003SE |
| K024316 | Nim-PrsIKN · Traditional | Medtronic Xomed, Inc. | 01/06/2003SE |
| K023147 | Analog Multiplexed Cable Telemetry (Amt) Electromyograph, Models AMT-16, AMT-8 & AMT-4IKN · Traditional | Bortec Biomedical, Ltd. | 12/12/2002SE |
| K022719 | Physical Monitoring Registration UnitIKN · Traditional | Maryrose Cusimano, Ph.D./Phil Reaston | 11/13/2002SE |
| K010590 | Neuropack Micro, Model MED-9100A SeriesIKN · Traditional | Nihon Kohden America, Inc. | 06/28/2001SE |
| K002104 | Combined Physiological Monitoring SystemIKN · Traditional | Maryrose Cusimano, Ph.D. & Scott Zeff | 10/10/2000SE |
| K001800 | Accuwarm Emg Heat LampIKN · Traditional | Rjl Associates, LLC | 09/12/2000SE |
| K001562 | Neuro Scan Medical Systems A4000IKN · Traditional | Neuro Scan Labs | 08/16/2000SE |
| K000812 | Neuro Scan Medical Systems, Models 302L Medicor (Laboratory) and 302P Advantage 3000…IKN · Traditional | Neurosoft, Inc. | 05/17/2000SE |
| K000220 | MA-300 Electromyography SystemIKN · Traditional | Motion Lab Systems, Inc. | 02/24/2000SE |
| K993878 | Je 2000IKN · Traditional | Jack'S Electrodes | 02/01/2000SE |
| K990766 | Cersr Electromyography SystemIKN · Traditional | Paraspinal Diagnostic Corp. | 08/27/1999SE |
| K984052 | Synergy Iom SystemIKN · Traditional | Oxford Instruments Medical Systems | 05/17/1999SE |
| K972419 | Toennies Neuroscreen SystemIKN · Traditional | Erich Jaeger, Inc. | 04/30/1998SE |
| K974385 | MLS Electromyographic PreamplifierIKN · Traditional | Motion Lab Systems, Inc. | 02/19/1998SE |
| K974010 | Advantage Emg System, Model #A100IKN · Traditional | Advantage Medical Division of Cme Telemetrix | 01/16/1998SE |
| K973355 | Advantage 3000IKN · Traditional | Advantage Medical Division of Cme Telemetrix | 12/05/1997SE |
| K941144 | Excel EmgIKN · Traditional | Excel Tech. , Ltd. | 11/07/1995SE |
| K942965 | Computer Dyno/Gonio/Myo GraphyIKN · Traditional | Infotronic Medical Engineering | 10/07/1995SE |
| K952655 | B & L ElectrodeIKN · Traditional | B & L Engineering | 09/28/1995SE |
| K944787 | Integrated Movement AnalyzerIKN · Traditional | Maryrose | 07/07/1995SE |
| K935368 | STC Diagnostic 8000IKN · Traditional | Sherman Technology Corp. | 05/01/1995SE |
| K930328 | Navigator & Traveler Evoked Postential ProductIKN · Traditional | Bio-Logic Systems Corp. | 07/02/1993SE |
| K922488 | Phasis ElectromyographIKN · Traditional | Biosound, Inc. | 03/02/1993SE |
| K911388 | CavomatIKN · Traditional | Wiest USA, Inc. | 12/04/1991SE |
| K901732 | Emg Accessory for PosturographyIKN · Traditional | Neurocom International, Inc. | 09/10/1991SE |
| K912071 | Space(Tm) 7500IKN · Traditional | F.M. Wiest USA, Inc. | 07/09/1991SE |
| K893130 | Emg Navigator & Emg TravelerIKN · Traditional | Bio-Logic Systems Corp. | 03/20/1990SE |
| K883781 | Nicolet Neuroport/Ace SystemIKN · Traditional | Nicolet Instrument Corp. | 06/05/1989SE |
| K890495 | Nicolet Viking II SystemIKN · Traditional | Nicolet Instrument Corp. | 03/16/1989SE |
| K880977 | ADR-2000 Ambulatory Data Recording SystemIKN · Traditional | Aaron Laboratories, Inc. | 04/13/1988SE |
| K880976 | AL-200B Muscle Activity IntegratorIKN · Traditional | Aaron Laboratories, Inc. | 04/13/1988SE |
| K880573 | Modified Nicolet Viking SystemIKN · Traditional | Nicolet Biomedical Instruments | 03/22/1988SE |
| K872836 | SpinoscopeIKN · Traditional | Diagnospine Fabrication, Inc. | 09/29/1987SE |
| K864660 | Model M402 Emg MonitorIKN · Traditional | Bio-Logic Devices | 02/04/1987SE |
| K864408 | EMG-1, Motor Nerve MonitorIKN · Traditional | Algotek, Inc. | 01/30/1987SE |
| K864641 | Ventex-IaIKN · Traditional | Ventech Corp. | 01/28/1987SE |
| K864630 | Kc/Emg Diagnostic ElectromyographIKN · Traditional | Chattanooga Group, Inc. | 12/29/1986SE |
| K862236 | Myolab II, Model ML-200IKN · Traditional | Motion Control, Inc. | 08/07/1986SE |
| K853804 | Vicon (Modification)IKN · Traditional | Oxford Metrics, Inc. | 12/27/1985SE |
| K842649 | Bath Tub Transfer ChairIKN · Traditional | Guardian Products Co., Inc. | 08/10/1984SE |
| K842956 | Nicolet VikingIKN · Traditional | Nicolet Biomedical Instruments | 08/03/1984SE |
| K842613 | Compact VisualIKN · Traditional | Nicolet Biomedical Instruments | 07/20/1984SE |
| K842612 | Compact AuditoryIKN · Traditional | Nicolet Biomedical Instruments | 07/20/1984SE |
| K842611 | CA2000IKN · Traditional | Nicolet Biomedical Instruments | 07/20/1984SE |
| K833927 | Electro-Myoscope 85IKN · Traditional | Biomedical Design Instruments | 12/27/1983SE |
| K830702 | Nicolet Emg SatelliteIKN · Traditional | Nicolet Biomedical Instruments | 07/12/1983SE |
| K823562 | Emg Modules for Polygraph SystemIKN · Traditional | Nihon Kohden America, Inc. | 01/14/1983SE |
| K822624 | O.T.E. Biomedica B.A.S.I.S. Model 2381IKN · Traditional | Del Mar Avionics | 10/06/1982SE |
| K821910 | Anesthesia & Brain MonitorIKN · Traditional | Datex Division Instrumentarium Corp. | 09/07/1982SE |
| K821237 | Neuromatic 2000IKN · Traditional | Disa Electronics | 05/21/1982SE |
| K812715 | Teca #Te 8IKN · Traditional | Teca, Inc. | 10/13/1981SE |
| K802637 | Teca MODEL-10 ElectromyographIKN · Traditional | Teca, Inc. | 11/26/1980SE |
| K800648 | Cadwell 7200IKN · Traditional | Cadwell Laboratories, Inc. | 04/21/1980SE |
| K791235 | Cadwell 7000 Electromyograph MachineIKN · Traditional | Cadwell Laboratories, Inc. | 08/16/1979SE |
| K790664 | Model 1309 Audio MonitorIKN · Traditional | Life-Tech Instruments, Inc. | 04/23/1979SE |
| K781399 | Teca Model B9 ElectromyographIKN · Traditional | Teca, Inc. | 09/20/1978SE |
| K780541 | Pressure Modules Models 1855 & 1856IKN · Traditional | Life-Tech Instruments, Inc. | 05/19/1978SE |
| K772005 | Myotone Emg MonitorIKN · Traditional | Micro Tronics Corp. | 11/23/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1935-2010 | Lumbar Matrix Scan, Diagnostic Electromyography System consisting of the CERSR…A full design review of the CERSR system was conducted in 7/2009. The audit revealed numerous design… | SpineMatrix Inc | 01/29/2010Terminated |