Electromyograph, Diagnostic

FDA product code IKN · 73 cleared devices

Class 2 Physical Medicine

Regulation: 21 CFR 890.1375
Review panel: NE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-11-23 – 2017-12-19

IKN 2017-12-19

Natus VikingQuest

Applicant Natus Neurology Incorporated

K number K172743

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IKN 2017-07-14

ViMove2

Applicant Dorsavi, Ltd.

K number K163150

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IKN 2017-03-01

Cadwell Sierra Summit, Cadwell Sierra Ascent

Applicant Cadwell Industries, Inc.

K number K162383

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IKN 2013-09-13

PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)

Applicant Oktx, LLC

K number K123902

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IKN 2013-08-01

MYOVISION 3.0 WIREFREE SYSTEM

Applicant Precision Biometrics, Inc.

K number K123399

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IKN 2012-02-02

CMAP PRO

Applicant Medical Technologies, Inc.

K number K113074

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IKN 2011-03-04

FOCUS EMG DEVICE

Applicant Teleemg, LLC USA

K number K102610

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IKN 2011-01-26

CERSR ELECTROMYOGRAPHY SYSTEM

Applicant Spinematrix, Inc.

K number K110048

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IKN 2009-09-11

UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1

Applicant Uroval

K number K083679

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IKN 2008-05-23

NEMUS SYSTEM; NEMUS PC PERIPHERAL

Applicant Eb Neuro S.P.A.

K number K073415

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IKN 2007-08-16

INSIGHT DISCOVERY

Applicant Fasstech

K number K063447

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IKN 2005-10-28

XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059

Applicant Excel Tech. , Ltd.

K number K052112

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IKN 2004-01-07

COMPREHENSIVE NEUROMUSCULAR PROFILER

Applicant Medical Technologies Unlimited, Inc.

K number K031995

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IKN 2003-11-28

CWAS 1000

Applicant Fasstech

K number K033452

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IKN 2003-10-10

INSIGHT MILLENNIUM III

Applicant Fasstech

K number K023209

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IKN 2003-01-06

NIM-PRS

Applicant Medtronic Xomed, Inc.

K number K024316

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IKN 2002-12-12

ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4

Applicant Bortec Biomedical, Ltd.

K number K023147

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IKN 2002-11-13

PHYSICAL MONITORING REGISTRATION UNIT

Applicant Maryrose Cusimano, Ph.D./Phil Reaston

K number K022719

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IKN 2001-06-28

NEUROPACK MICRO, MODEL MED-9100A SERIES

Applicant Nihon Kohden America, Inc.

K number K010590

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IKN 2000-10-10

COMBINED PHYSIOLOGICAL MONITORING SYSTEM

Applicant Maryrose Cusimano, Ph.D. & Scott Zeff

K number K002104

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IKN 2000-09-12

ACCUWARM EMG HEAT LAMP

Applicant Rjl Associates, LLC

K number K001800

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IKN 2000-08-16

NEURO SCAN MEDICAL SYSTEMS A4000

Applicant Neuro Scan Labs

K number K001562

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IKN 2000-05-17

NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE)

Applicant Neurosoft, Inc.

K number K000812

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IKN 2000-02-24

MA-300 ELECTROMYOGRAPHY SYSTEM

Applicant Motion Lab Systems, Inc.

K number K000220

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IKN 2000-02-01

JE 2000

Applicant Jack'S Electrodes

K number K993878

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IKN 1999-08-27

CERSR ELECTROMYOGRAPHY SYSTEM

Applicant Paraspinal Diagnostic Corp.

K number K990766

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IKN 1999-05-17

SYNERGY IOM SYSTEM

Applicant Oxford Instruments Medical Systems

K number K984052

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IKN 1998-04-30

TOENNIES NEUROSCREEN SYSTEM

Applicant Erich Jaeger, Inc.

K number K972419

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IKN 1998-02-19

MLS ELECTROMYOGRAPHIC PREAMPLIFIER

Applicant Motion Lab Systems, Inc.

K number K974385

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IKN 1998-01-16

ADVANTAGE EMG SYSTEM, MODEL #A100

Applicant Advantage Medical Division of Cme Telemetrix

K number K974010

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IKN 1997-12-05

ADVANTAGE 3000

Applicant Advantage Medical Division of Cme Telemetrix

K number K973355

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IKN 1995-11-07

EXCEL EMG

Applicant Excel Tech. , Ltd.

K number K941144

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IKN 1995-10-07

COMPUTER DYNO/GONIO/MYO GRAPHY

Applicant Infotronic Medical Engineering

K number K942965

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IKN 1995-09-28

B & L ELECTRODE

Applicant B & L Engineering

K number K952655

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IKN 1995-07-07

INTEGRATED MOVEMENT ANALYZER

Applicant Maryrose

K number K944787

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IKN 1995-05-01

STC DIAGNOSTIC 8000

Applicant Sherman Technology Corp.

K number K935368

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IKN 1993-07-02

NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT

Applicant Bio-Logic Systems Corp.

K number K930328

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IKN 1993-03-02

PHASIS ELECTROMYOGRAPH

Applicant Biosound, Inc.

K number K922488

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IKN 1991-12-04

CAVOMAT

Applicant Wiest USA, Inc.

K number K911388

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IKN 1991-09-10

EMG ACCESSORY FOR POSTUROGRAPHY

Applicant Neurocom International, Inc.

K number K901732

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IKN 1991-07-09

SPACE(TM) 7500

Applicant F.M. Wiest USA, Inc.

K number K912071

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IKN 1990-03-20

EMG NAVIGATOR & EMG TRAVELER

Applicant Bio-Logic Systems Corp.

K number K893130

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IKN 1989-06-05

NICOLET NEUROPORT/ACE SYSTEM

Applicant Nicolet Instrument Corp.

K number K883781

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IKN 1989-03-16

NICOLET VIKING II SYSTEM

Applicant Nicolet Instrument Corp.

K number K890495

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IKN 1988-04-13

ADR-2000 AMBULATORY DATA RECORDING SYSTEM

Applicant Aaron Laboratories, Inc.

K number K880977

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IKN 1988-04-13

AL-200B MUSCLE ACTIVITY INTEGRATOR

Applicant Aaron Laboratories, Inc.

K number K880976

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IKN 1988-03-22

MODIFIED NICOLET VIKING SYSTEM

Applicant Nicolet Biomedical Instruments

K number K880573

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IKN 1987-09-29

SPINOSCOPE

Applicant Diagnospine Fabrication, Inc.

K number K872836

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IKN 1987-02-04

MODEL M402 EMG MONITOR

Applicant Bio-Logic Devices

K number K864660

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IKN 1987-01-30

EMG-1, MOTOR NERVE MONITOR

Applicant Algotek, Inc.

K number K864408

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IKN 1987-01-28

VENTEX-IA

Applicant Ventech Corp.

K number K864641

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IKN 1986-12-29

KC/EMG DIAGNOSTIC ELECTROMYOGRAPH

Applicant Chattanooga Group, Inc.

K number K864630

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IKN 1986-08-07

MYOLAB II, MODEL ML-200

Applicant Motion Control, Inc.

K number K862236

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IKN 1985-12-27

VICON (MODIFICATION)

Applicant Oxford Metrics, Inc.

K number K853804

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IKN 1984-08-10

BATH TUB TRANSFER CHAIR

Applicant Guardian Products Co., Inc.

K number K842649

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IKN 1984-08-03

NICOLET VIKING

Applicant Nicolet Biomedical Instruments

K number K842956

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IKN 1984-07-20

COMPACT VISUAL

Applicant Nicolet Biomedical Instruments

K number K842613

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IKN 1984-07-20

COMPACT AUDITORY

Applicant Nicolet Biomedical Instruments

K number K842612

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IKN 1984-07-20

CA2000

Applicant Nicolet Biomedical Instruments

K number K842611

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IKN 1983-12-27

ELECTRO-MYOSCOPE 85

Applicant Biomedical Design Instruments

K number K833927

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IKN 1983-07-12

NICOLET EMG SATELLITE

Applicant Nicolet Biomedical Instruments

K number K830702

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IKN 1983-01-14

EMG MODULES FOR POLYGRAPH SYSTEM

Applicant Nihon Kohden America, Inc.

K number K823562

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IKN 1982-10-06

O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381

Applicant Del Mar Avionics

K number K822624

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IKN 1982-09-07

ANESTHESIA & BRAIN MONITOR

Applicant Datex Division Instrumentarium Corp.

K number K821910

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IKN 1982-05-21

NEUROMATIC 2000

Applicant Disa Electronics

K number K821237

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IKN 1981-10-13

TECA #TE 8

Applicant Teca, Inc.

K number K812715

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IKN 1980-11-26

TECA MODEL-10 ELECTROMYOGRAPH

Applicant Teca, Inc.

K number K802637

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IKN 1980-04-21

CADWELL 7200

Applicant Cadwell Laboratories, Inc.

K number K800648

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IKN 1979-08-16

CADWELL 7000 ELECTROMYOGRAPH MACHINE

Applicant Cadwell Laboratories, Inc.

K number K791235

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IKN 1979-04-23

MODEL 1309 AUDIO MONITOR

Applicant Life-Tech Instruments, Inc.

K number K790664

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IKN 1978-09-20

TECA MODEL B9 ELECTROMYOGRAPH

Applicant Teca, Inc.

K number K781399

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IKN 1978-05-19

PRESSURE MODULES MODELS 1855 & 1856

Applicant Life-Tech Instruments, Inc.

K number K780541

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IKN 1977-11-23

MYOTONE EMG MONITOR

Applicant Micro Tronics Corp.

K number K772005

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