Product code IKN
- Device name
- Electromyograph, Diagnostic
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.1375
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172743 | Natus VikingQuest | Natus Neurology Incorporated | 2017-12-19 |
| K163150 | ViMove2 | Dorsavi, Ltd. | 2017-07-14 |
| K162383 | Cadwell Sierra Summit, Cadwell Sierra Ascent | Cadwell Industries, Inc. | 2017-03-01 |
| K142494 | ViMove | Dorsavi, Ltd. | 2015-05-28 |
| K131094 | VIMOVE | Dorsa VI Pty., Ltd. | 2014-07-11 |
| K123902 | PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) | Oktx, LLC | 2013-09-13 |
| K123399 | MYOVISION 3.0 WIREFREE SYSTEM | Precision Biometrics, Inc. | 2013-08-01 |
| K113074 | CMAP PRO | Medical Technologies, Inc. | 2012-02-02 |
| K102610 | FOCUS EMG DEVICE | Teleemg, LLC USA | 2011-03-04 |
| K110048 | CERSR ELECTROMYOGRAPHY SYSTEM | Spinematrix, Inc. | 2011-01-26 |
| K083679 | UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 | Uroval | 2009-09-11 |
| K073415 | NEMUS SYSTEM; NEMUS PC PERIPHERAL | Eb Neuro S.P.A. | 2008-05-23 |
| K063447 | INSIGHT DISCOVERY | Fasstech | 2007-08-16 |
| K052112 | XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 | Excel Tech. , Ltd. | 2005-10-28 |
| K031995 | COMPREHENSIVE NEUROMUSCULAR PROFILER | Medical Technologies Unlimited, Inc. | 2004-01-07 |
| K033452 | CWAS 1000 | Fasstech | 2003-11-28 |
| K023209 | INSIGHT MILLENNIUM III | Fasstech | 2003-10-10 |
| K024316 | NIM-PRS | Medtronic Xomed, Inc. | 2003-01-06 |
| K023147 | ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4 | Bortec Biomedical, Ltd. | 2002-12-12 |
| K022719 | PHYSICAL MONITORING REGISTRATION UNIT | Maryrose Cusimano, Ph.D./Phil Reaston | 2002-11-13 |
| K010590 | NEUROPACK MICRO, MODEL MED-9100A SERIES | Nihon Kohden America, Inc. | 2001-06-28 |
| K002104 | COMBINED PHYSIOLOGICAL MONITORING SYSTEM | Maryrose Cusimano, Ph.D. & Scott Zeff | 2000-10-10 |
| K001800 | ACCUWARM EMG HEAT LAMP | Rjl Associates, LLC | 2000-09-12 |
| K001562 | NEURO SCAN MEDICAL SYSTEMS A4000 | Neuro Scan Labs | 2000-08-16 |
| K000812 | NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE) | Neurosoft, Inc. | 2000-05-17 |
| K000220 | MA-300 ELECTROMYOGRAPHY SYSTEM | Motion Lab Systems, Inc. | 2000-02-24 |
| K993878 | JE 2000 | Jack'S Electrodes | 2000-02-01 |
| K990766 | CERSR ELECTROMYOGRAPHY SYSTEM | Paraspinal Diagnostic Corp. | 1999-08-27 |
| K984052 | SYNERGY IOM SYSTEM | Oxford Instruments Medical Systems | 1999-05-17 |
| K972419 | TOENNIES NEUROSCREEN SYSTEM | Erich Jaeger, Inc. | 1998-04-30 |
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| 08056446901090 | NExT Station Advanced | EB NEURO SPA | 2025-05-19 |
| G012BRCP01 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012MC0006 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012BRCP02 | BioStamp® nPoint | Medidata Solutions, Inc. | 2021-04-01 |
| G012BRCP03 | BioStamp® | Medidata Solutions, Inc. | 2021-04-01 |
| G012BRCS02 | BioStamp® | Medidata Solutions, Inc. | 2021-04-01 |
| G012BRCT01 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012BSPS01 | BioStamp® | Medidata Solutions, Inc. | 2021-04-01 |
| G012MC0003 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012MC0004 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012MC0005 | BioStamp nPoint™ | Medidata Solutions, Inc. | 2021-04-01 |
| G012BRCD02 | BioStamp® | Medidata Solutions, Inc. | 2021-04-01 |
| G012BRCA05 | BioStamp® | Medidata Solutions, Inc. | 2021-04-01 |
| G012BRCA02 | BioStamp® nPoint | Medidata Solutions, Inc. | 2021-04-01 |
| G012MC00022 | BioStamp® nPoint | Medidata Solutions, Inc. | 2021-03-01 |
| 08056446900642 | Galileo NT Line Software | EB NEURO SPA | 2020-05-25 |
| 08056446900260 | R-KEY (Dedicated Keyboard) | EB NEURO SPA | 2019-05-24 |
| 08056446900246 | Power-LAN Connection Box | EB NEURO SPA | 2019-05-24 |
| 08056446900239 | NeMus 1 | EB NEURO SPA | 2019-05-24 |
| 08056446900222 | NeMus 1 | EB NEURO SPA | 2019-05-24 |
| 08056446900215 | NeMus PC PERIPHERAL | EB NEURO SPA | 2019-05-24 |
| 08056446900253 | Power-LAN Connection Box USB | EB NEURO SPA | 2019-04-10 |
| 08055765540003 | FREMSLIFE | FREMSLIFE SRL | 2018-01-28 |