Atlas FDA

IKN

75 FDA 510(k) clearances · Product code

87 daysmedian time to decision
307 days90th percentile
75clearances measured

FDA profile

Official device name
Electromyograph, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 890.1375
Medical specialty
Physical Medicine
Flags
Third-party review eligible
Adverse events (MAUDE)
2001: 1 · 2002: 3 · 2004: 2 · 2013: 24 · 2015: 13 · 2016: 11
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Natus VikingQuest (K172743)Natus Neurology Incorporated2017-12-19
ViMove2 (K163150)Dorsavi, Ltd.2017-07-14
Cadwell Sierra Summit, Cadwell Sierra Ascent (K162383)Cadwell Industries, Inc.2017-03-01
ViMove (K142494)Dorsavi, Ltd.2015-05-28
VIMOVE (K131094)Dorsa VI Pty., Ltd.2014-07-11
PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) (K123902)Oktx, LLC2013-09-13
MYOVISION 3.0 WIREFREE SYSTEM (K123399)Precision Biometrics, Inc.2013-08-01
CMAP PRO (K113074)Medical Technologies, Inc.2012-02-02
FOCUS EMG DEVICE (K102610)Teleemg, LLC USA2011-03-04
CERSR ELECTROMYOGRAPHY SYSTEM (K110048)Spinematrix, Inc.2011-01-26
UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 (K083679)Uroval2009-09-11
NEMUS SYSTEM; NEMUS PC PERIPHERAL (K073415)Eb Neuro S.P.A.2008-05-23
INSIGHT DISCOVERY (K063447)Fasstech2007-08-16
XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 (K052112)Excel Tech. , Ltd.2005-10-28
COMPREHENSIVE NEUROMUSCULAR PROFILER (K031995)Medical Technologies Unlimited, Inc.2004-01-07
CWAS 1000 (K033452)Fasstech2003-11-28
INSIGHT MILLENNIUM III (K023209)Fasstech2003-10-10
NIM-PRS (K024316)Medtronic Xomed, Inc.2003-01-06
ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4 (K023147)Bortec Biomedical, Ltd.2002-12-12
PHYSICAL MONITORING REGISTRATION UNIT (K022719)Maryrose Cusimano, Ph.D./Phil Reaston2002-11-13
NEUROPACK MICRO, MODEL MED-9100A SERIES (K010590)Nihon Kohden America, Inc.2001-06-28
COMBINED PHYSIOLOGICAL MONITORING SYSTEM (K002104)Maryrose Cusimano, Ph.D. & Scott Zeff2000-10-10
ACCUWARM EMG HEAT LAMP (K001800)Rjl Associates, LLC2000-09-12
NEURO SCAN MEDICAL SYSTEMS A4000 (K001562)Neuro Scan Labs2000-08-16
NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE) (K000812)Neurosoft, Inc.2000-05-17
MA-300 ELECTROMYOGRAPHY SYSTEM (K000220)Motion Lab Systems, Inc.2000-02-24
JE 2000 (K993878)Jack'S Electrodes2000-02-01
CERSR ELECTROMYOGRAPHY SYSTEM (K990766)Paraspinal Diagnostic Corp.1999-08-27
SYNERGY IOM SYSTEM (K984052)Oxford Instruments Medical Systems1999-05-17
TOENNIES NEUROSCREEN SYSTEM (K972419)Erich Jaeger, Inc.1998-04-30
MLS ELECTROMYOGRAPHIC PREAMPLIFIER (K974385)Motion Lab Systems, Inc.1998-02-19
ADVANTAGE EMG SYSTEM, MODEL #A100 (K974010)Advantage Medical Division of Cme Telemetrix1998-01-16
ADVANTAGE 3000 (K973355)Advantage Medical Division of Cme Telemetrix1997-12-05
EXCEL EMG (K941144)Excel Tech. , Ltd.1995-11-07
COMPUTER DYNO/GONIO/MYO GRAPHY (K942965)Infotronic Medical Engineering1995-10-07
B & L ELECTRODE (K952655)B & L Engineering1995-09-28
INTEGRATED MOVEMENT ANALYZER (K944787)Maryrose1995-07-07
STC DIAGNOSTIC 8000 (K935368)Sherman Technology Corp.1995-05-01
NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT (K930328)Bio-Logic Systems Corp.1993-07-02
PHASIS ELECTROMYOGRAPH (K922488)Biosound, Inc.1993-03-02
CAVOMAT (K911388)Wiest USA, Inc.1991-12-04
EMG ACCESSORY FOR POSTUROGRAPHY (K901732)Neurocom International, Inc.1991-09-10
SPACE(TM) 7500 (K912071)F.M. Wiest USA, Inc.1991-07-09
EMG NAVIGATOR & EMG TRAVELER (K893130)Bio-Logic Systems Corp.1990-03-20
NICOLET NEUROPORT/ACE SYSTEM (K883781)Nicolet Instrument Corp.1989-06-05
NICOLET VIKING II SYSTEM (K890495)Nicolet Instrument Corp.1989-03-16
ADR-2000 AMBULATORY DATA RECORDING SYSTEM (K880977)Aaron Laboratories, Inc.1988-04-13
AL-200B MUSCLE ACTIVITY INTEGRATOR (K880976)Aaron Laboratories, Inc.1988-04-13
MODIFIED NICOLET VIKING SYSTEM (K880573)Nicolet Biomedical Instruments1988-03-22
SPINOSCOPE (K872836)Diagnospine Fabrication, Inc.1987-09-29
MODEL M402 EMG MONITOR (K864660)Bio-Logic Devices1987-02-04
EMG-1, MOTOR NERVE MONITOR (K864408)Algotek, Inc.1987-01-30
VENTEX-IA (K864641)Ventech Corp.1987-01-28
KC/EMG DIAGNOSTIC ELECTROMYOGRAPH (K864630)Chattanooga Group, Inc.1986-12-29
MYOLAB II, MODEL ML-200 (K862236)Motion Control, Inc.1986-08-07
VICON (MODIFICATION) (K853804)Oxford Metrics, Inc.1985-12-27
BATH TUB TRANSFER CHAIR (K842649)Guardian Products Co., Inc.1984-08-10
NICOLET VIKING (K842956)Nicolet Biomedical Instruments1984-08-03
CA2000 (K842611)Nicolet Biomedical Instruments1984-07-20
COMPACT AUDITORY (K842612)Nicolet Biomedical Instruments1984-07-20
COMPACT VISUAL (K842613)Nicolet Biomedical Instruments1984-07-20
ELECTRO-MYOSCOPE 85 (K833927)Biomedical Design Instruments1983-12-27
NICOLET EMG SATELLITE (K830702)Nicolet Biomedical Instruments1983-07-12
EMG MODULES FOR POLYGRAPH SYSTEM (K823562)Nihon Kohden America, Inc.1983-01-14
O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381 (K822624)Del Mar Avionics1982-10-06
ANESTHESIA & BRAIN MONITOR (K821910)Datex Division Instrumentarium Corp.1982-09-07
NEUROMATIC 2000 (K821237)Disa Electronics1982-05-21
TECA #TE 8 (K812715)Teca, Inc.1981-10-13
TECA MODEL-10 ELECTROMYOGRAPH (K802637)Teca, Inc.1980-11-26
CADWELL 7200 (K800648)Cadwell Laboratories, Inc.1980-04-21
CADWELL 7000 ELECTROMYOGRAPH MACHINE (K791235)Cadwell Laboratories, Inc.1979-08-16
MODEL 1309 AUDIO MONITOR (K790664)Life-Tech Instruments, Inc.1979-04-23
TECA MODEL B9 ELECTROMYOGRAPH (K781399)Teca, Inc.1978-09-20
PRESSURE MODULES MODELS 1855 & 1856 (K780541)Life-Tech Instruments, Inc.1978-05-19
MYOTONE EMG MONITOR (K772005)Micro Tronics Corp.1977-11-23

Track IKN automatically

Every clearance here is in the API, with alerts when new ones post.