Product Code: IKN FDA class 2 21 CFR 890.1375

Electromyograph, Diagnostic

Physical Medicine

A Diagnostic Electromyograph is a device used in Physical Medicine and neurology to record electrical activity produced by skeletal muscles, assisting in the diagnosis of neuromuscular disorders, nerve injuries, and conditions such as carpal tunnel syndrome and ALS. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is IKN, regulated under 21 CFR 890.1375, within the Physical Medicine medical specialty. This device is eligible for third party review, meaning the 510(k) submission may be reviewed by an FDA-accredited third party organization.

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FEI Numbers

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Unique Applicants

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Basic Information

Product Code: IKN
Device Class: FDA class 2
Regulation Number: 890.1375
Medical Specialty: Physical Medicine
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 75 510(k) clearances via K numbers.

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