IKN — Electromyograph, Diagnostic Class II
FDA product code IKN covers "Electromyograph, Diagnostic", a Class II medical device regulated under 21 CFR 890.1375. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IKN
- Device Class
- Class II
- Regulation Number
- 890.1375
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K172743 | natus neurology incorporated | Natus VikingQuest | December 19, 2017 |
| K163150 | dorsavi | ViMove2 | July 14, 2017 |
| K162383 | cadwell industries | Cadwell Sierra Summit, Cadwell Sierra Ascent | March 1, 2017 |
| K142494 | dorsavi | ViMove | May 28, 2015 |
| K131094 | dorsa vi pty | VIMOVE | July 11, 2014 |
| K123902 | oktx | PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) | September 13, 2013 |
| K123399 | precision biometrics | MYOVISION 3.0 WIREFREE SYSTEM | August 1, 2013 |
| K113074 | medical technologies | CMAP PRO | February 2, 2012 |
| K102610 | teleemg, llc usa | FOCUS EMG DEVICE | March 4, 2011 |
| K110048 | spinematrix | CERSR ELECTROMYOGRAPHY SYSTEM | January 26, 2011 |
| K083679 | uroval | UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 | September 11, 2009 |
| K073415 | eb neuro | NEMUS SYSTEM; NEMUS PC PERIPHERAL | May 23, 2008 |
| K063447 | fasstech | INSIGHT DISCOVERY | August 16, 2007 |
| K052112 | excel tech. | XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 | October 28, 2005 |
| K031995 | medical technologies unlimited | COMPREHENSIVE NEUROMUSCULAR PROFILER | January 7, 2004 |
| K033452 | fasstech | CWAS 1000 | November 28, 2003 |
| K023209 | fasstech | INSIGHT MILLENNIUM III | October 10, 2003 |
| K024316 | medtronic xomed | NIM-PRS | January 6, 2003 |
| K023147 | bortec biomedical | ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & | December 12, 2002 |
| K022719 | maryrose cusimano, ph.d./phil reaston | PHYSICAL MONITORING REGISTRATION UNIT | November 13, 2002 |