FDA Product Code
FDA Product Code IKN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.1375
510(k) Clearances — 75 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K172743 | Natus VikingQuest | Natus Neurology Incorporated | 2017-12-19 | Special | PDF ↗ |
| K163150 | ViMove2 | Dorsavi, Ltd. | 2017-07-14 | Special | PDF ↗ |
| K162383 | Cadwell Sierra Summit, Cadwell Sierra Ascent | Cadwell Industries, Inc. | 2017-03-01 | Traditional | PDF ↗ |
| K142494 | ViMove | Dorsavi, Ltd. | 2015-05-28 | Traditional | PDF ↗ |
| K131094 | VIMOVE | Dorsa VI Pty., Ltd. | 2014-07-11 | Traditional | PDF ↗ |
| K123902 | PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) | Oktx, LLC | 2013-09-13 | Traditional | PDF ↗ |
| K123399 | MYOVISION 3.0 WIREFREE SYSTEM | Precision Biometrics, Inc. | 2013-08-01 | Traditional | PDF ↗ |
| K113074 | CMAP PRO | Medical Technologies, Inc. | 2012-02-02 | Traditional | PDF ↗ |
| K102610 | FOCUS EMG DEVICE | Teleemg, LLC USA | 2011-03-04 | Traditional | PDF ↗ |
| K110048 | CERSR ELECTROMYOGRAPHY SYSTEM | Spinematrix, Inc. | 2011-01-26 | Special | PDF ↗ |
| K083679 | UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 | Uroval | 2009-09-11 | Traditional | PDF ↗ |
| K073415 | NEMUS SYSTEM; NEMUS PC PERIPHERAL | Eb Neuro S.P.A. | 2008-05-23 | Traditional | PDF ↗ |
| K063447 | INSIGHT DISCOVERY | Fasstech | 2007-08-16 | Traditional | PDF ↗ |
| K052112 | XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 | Excel Tech. , Ltd. | 2005-10-28 | Special | PDF ↗ |
| K031995 | COMPREHENSIVE NEUROMUSCULAR PROFILER | Medical Technologies Unlimited, Inc. | 2004-01-07 | Traditional | PDF ↗ |
| K033452 | CWAS 1000 | Fasstech | 2003-11-28 | Traditional | PDF ↗ |
| K023209 | INSIGHT MILLENNIUM III | Fasstech | 2003-10-10 | Traditional | PDF ↗ |
| K024316 | NIM-PRS | Medtronic Xomed, Inc. | 2003-01-06 | Traditional | PDF ↗ |
| K023147 | ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4 | Bortec Biomedical, Ltd. | 2002-12-12 | Traditional | PDF ↗ |
| K022719 | PHYSICAL MONITORING REGISTRATION UNIT | Maryrose Cusimano, Ph.D./Phil Reaston | 2002-11-13 | Traditional | PDF ↗ |
| K010590 | NEUROPACK MICRO, MODEL MED-9100A SERIES | Nihon Kohden America, Inc. | 2001-06-28 | Traditional | PDF ↗ |
| K002104 | COMBINED PHYSIOLOGICAL MONITORING SYSTEM | Maryrose Cusimano, Ph.D. & Scott Zeff | 2000-10-10 | Traditional | PDF ↗ |
| K001800 | ACCUWARM EMG HEAT LAMP | Rjl Associates, LLC | 2000-09-12 | Traditional | PDF ↗ |
| K001562 | NEURO SCAN MEDICAL SYSTEMS A4000 | Neuro Scan Labs | 2000-08-16 | Traditional | PDF ↗ |
| K000812 | NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE) | Neurosoft, Inc. | 2000-05-17 | Traditional | PDF ↗ |
| K000220 | MA-300 ELECTROMYOGRAPHY SYSTEM | Motion Lab Systems, Inc. | 2000-02-24 | Traditional | PDF ↗ |
| K993878 | JE 2000 | Jack'S Electrodes | 2000-02-01 | Traditional | PDF ↗ |
| K990766 | CERSR ELECTROMYOGRAPHY SYSTEM | Paraspinal Diagnostic Corp. | 1999-08-27 | Traditional | PDF ↗ |
| K984052 | SYNERGY IOM SYSTEM | Oxford Instruments Medical Systems | 1999-05-17 | Traditional | PDF ↗ |
| K972419 | TOENNIES NEUROSCREEN SYSTEM | Erich Jaeger, Inc. | 1998-04-30 | Traditional | PDF ↗ |
| K974385 | MLS ELECTROMYOGRAPHIC PREAMPLIFIER | Motion Lab Systems, Inc. | 1998-02-19 | Traditional | PDF ↗ |
| K974010 | ADVANTAGE EMG SYSTEM, MODEL #A100 | Advantage Medical Division of Cme Telemetrix | 1998-01-16 | Traditional | PDF ↗ |
| K973355 | ADVANTAGE 3000 | Advantage Medical Division of Cme Telemetrix | 1997-12-05 | Traditional | PDF ↗ |
| K941144 | EXCEL EMG | Excel Tech. , Ltd. | 1995-11-07 | Traditional | PDF ↗ |
| K942965 | COMPUTER DYNO/GONIO/MYO GRAPHY | Infotronic Medical Engineering | 1995-10-07 | Traditional | PDF ↗ |
| K952655 | B & L ELECTRODE | B & L Engineering | 1995-09-28 | Traditional | PDF ↗ |
| K944787 | INTEGRATED MOVEMENT ANALYZER | Maryrose | 1995-07-07 | Traditional | PDF ↗ |
| K935368 | STC DIAGNOSTIC 8000 | Sherman Technology Corp. | 1995-05-01 | Traditional | PDF ↗ |
| K930328 | NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT | Bio-Logic Systems Corp. | 1993-07-02 | Traditional | PDF ↗ |
| K922488 | PHASIS ELECTROMYOGRAPH | Biosound, Inc. | 1993-03-02 | Traditional | PDF ↗ |
| K911388 | CAVOMAT | Wiest USA, Inc. | 1991-12-04 | Traditional | PDF ↗ |
| K901732 | EMG ACCESSORY FOR POSTUROGRAPHY | Neurocom International, Inc. | 1991-09-10 | Traditional | PDF ↗ |
| K912071 | SPACE(TM) 7500 | F.M. Wiest USA, Inc. | 1991-07-09 | Traditional | PDF ↗ |
| K893130 | EMG NAVIGATOR & EMG TRAVELER | Bio-Logic Systems Corp. | 1990-03-20 | Traditional | PDF ↗ |
| K883781 | NICOLET NEUROPORT/ACE SYSTEM | Nicolet Instrument Corp. | 1989-06-05 | Traditional | PDF ↗ |
| K890495 | NICOLET VIKING II SYSTEM | Nicolet Instrument Corp. | 1989-03-16 | Traditional | PDF ↗ |
| K880977 | ADR-2000 AMBULATORY DATA RECORDING SYSTEM | Aaron Laboratories, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K880976 | AL-200B MUSCLE ACTIVITY INTEGRATOR | Aaron Laboratories, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K880573 | MODIFIED NICOLET VIKING SYSTEM | Nicolet Biomedical Instruments | 1988-03-22 | Traditional | PDF ↗ |
| K872836 | SPINOSCOPE | Diagnospine Fabrication, Inc. | 1987-09-29 | Traditional | PDF ↗ |
| K864660 | MODEL M402 EMG MONITOR | Bio-Logic Devices | 1987-02-04 | Traditional | PDF ↗ |
| K864408 | EMG-1, MOTOR NERVE MONITOR | Algotek, Inc. | 1987-01-30 | Traditional | PDF ↗ |
| K864641 | VENTEX-IA | Ventech Corp. | 1987-01-28 | Traditional | PDF ↗ |
| K864630 | KC/EMG DIAGNOSTIC ELECTROMYOGRAPH | Chattanooga Group, Inc. | 1986-12-29 | Traditional | PDF ↗ |
| K862236 | MYOLAB II, MODEL ML-200 | Motion Control, Inc. | 1986-08-07 | Traditional | PDF ↗ |
| K853804 | VICON (MODIFICATION) | Oxford Metrics, Inc. | 1985-12-27 | Traditional | PDF ↗ |
| K842649 | BATH TUB TRANSFER CHAIR | Guardian Products Co., Inc. | 1984-08-10 | Traditional | PDF ↗ |
| K842956 | NICOLET VIKING | Nicolet Biomedical Instruments | 1984-08-03 | Traditional | PDF ↗ |
| K842612 | COMPACT AUDITORY | Nicolet Biomedical Instruments | 1984-07-20 | Traditional | PDF ↗ |
| K842611 | CA2000 | Nicolet Biomedical Instruments | 1984-07-20 | Traditional | PDF ↗ |
| K842613 | COMPACT VISUAL | Nicolet Biomedical Instruments | 1984-07-20 | Traditional | PDF ↗ |
| K833927 | ELECTRO-MYOSCOPE 85 | Biomedical Design Instruments | 1983-12-27 | Traditional | PDF ↗ |
| K830702 | NICOLET EMG SATELLITE | Nicolet Biomedical Instruments | 1983-07-12 | Traditional | PDF ↗ |
| K823562 | EMG MODULES FOR POLYGRAPH SYSTEM | Nihon Kohden America, Inc. | 1983-01-14 | Traditional | PDF ↗ |
| K822624 | O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381 | Del Mar Avionics | 1982-10-06 | Traditional | PDF ↗ |
| K821910 | ANESTHESIA & BRAIN MONITOR | Datex Division Instrumentarium Corp. | 1982-09-07 | Traditional | PDF ↗ |
| K821237 | NEUROMATIC 2000 | Disa Electronics | 1982-05-21 | Traditional | PDF ↗ |
| K812715 | TECA #TE 8 | Teca, Inc. | 1981-10-13 | Traditional | PDF ↗ |
| K802637 | TECA MODEL-10 ELECTROMYOGRAPH | Teca, Inc. | 1980-11-26 | Traditional | PDF ↗ |
| K800648 | CADWELL 7200 | Cadwell Laboratories, Inc. | 1980-04-21 | Traditional | PDF ↗ |
| K791235 | CADWELL 7000 ELECTROMYOGRAPH MACHINE | Cadwell Laboratories, Inc. | 1979-08-16 | Traditional | PDF ↗ |
| K790664 | MODEL 1309 AUDIO MONITOR | Life-Tech Instruments, Inc. | 1979-04-23 | Traditional | PDF ↗ |
| K781399 | TECA MODEL B9 ELECTROMYOGRAPH | Teca, Inc. | 1978-09-20 | Traditional | PDF ↗ |
| K780541 | PRESSURE MODULES MODELS 1855 & 1856 | Life-Tech Instruments, Inc. | 1978-05-19 | Traditional | PDF ↗ |
| K772005 | MYOTONE EMG MONITOR | Micro Tronics Corp. | 1977-11-23 | Traditional | PDF ↗ |
Product code IKN · Class II · Physical Medicine. Data: openFDA.