IKN · Electromyograph, Diagnostic
Physical Medicine · 21 CFR 890.1375 · Class 2
Overview
| Product Code | IKN |
|---|---|
| Device Name | Electromyograph, Diagnostic |
| Regulation | 21 CFR 890.1375 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
Identification
A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 75)
Showing 20 most recent of 75 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K172743 | Natus VikingQuest | Natus Neurology Incorporated | Dec 19, 2017 | SESE |
| K163150 | ViMove2 | Dorsavi, Ltd. | Jul 14, 2017 | SESE |
| K162383 | Cadwell Sierra Summit, Cadwell Sierra Ascent | Cadwell Industries, Inc. | Mar 1, 2017 | SESE |
| K142494 | ViMove | Dorsavi, Ltd. | May 28, 2015 | SESE |
| K131094 | VIMOVE | Dorsa VI Pty., Ltd. | Jul 11, 2014 | SESE |
| K123902 | PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) | Oktx, LLC | Sep 13, 2013 | SESE |
| K123399 | MYOVISION 3.0 WIREFREE SYSTEM | Precision Biometrics, Inc. | Aug 1, 2013 | SESE |
| K113074 | CMAP PRO | Medical Technologies, Inc. | Feb 2, 2012 | SESE |
| K102610 | FOCUS EMG DEVICE | Teleemg, LLC USA | Mar 4, 2011 | SESE |
| K110048 | CERSR ELECTROMYOGRAPHY SYSTEM | Spinematrix, Inc. | Jan 26, 2011 | SESE |
| K083679 | UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 | Uroval | Sep 11, 2009 | SESE |
| K073415 | NEMUS SYSTEM; NEMUS PC PERIPHERAL | Eb Neuro S.P.A. | May 23, 2008 | SESE |
| K063447 | INSIGHT DISCOVERY | Fasstech | Aug 16, 2007 | SESE |
| K052112 | XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 | Excel Tech. , Ltd. | Oct 28, 2005 | SESE |
| K031995 | COMPREHENSIVE NEUROMUSCULAR PROFILER | Medical Technologies Unlimited, Inc. | Jan 7, 2004 | SESE |
| K033452 | CWAS 1000 | Fasstech | Nov 28, 2003 | SESE |
| K023209 | INSIGHT MILLENNIUM III | Fasstech | Oct 10, 2003 | SESE |
| K024316 | NIM-PRS | Medtronic Xomed, Inc. | Jan 6, 2003 | SESE |
| K023147 | ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4 | Bortec Biomedical, Ltd. | Dec 12, 2002 | SESE |
| K022719 | PHYSICAL MONITORING REGISTRATION UNIT | Maryrose Cusimano, Ph.D./Phil Reaston | Nov 13, 2002 | SESE |
Top Applicants
- Nicolet Biomedical Instruments — 6 clearances
- Fasstech — 3 clearances
- Teca, Inc. — 3 clearances
- Aaron Laboratories, Inc. — 2 clearances
- Advantage Medical Division of Cme Telemetrix — 2 clearances
