Product code IKN— Physical Medicine
CERSR ELECTROMYOGRAPHY SYSTEM
- Classification name
- Electromyograph, Diagnostic
- Device class
- Class 2
- Regulation
- 21 CFR 890.1375
- Advisory panel
- Physical Medicine
- Total cleared
- 75
- First cleared
- Most recent
Market context for product code IKN
FDA has cleared devices under product code IKN between 1977 and 2017, filed by 56 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2017
- 2015
- 2014
- 2013
- 2012
- 2011
- 2009
- 2008
- 2007
- 2005
- 2004
- 2003
- 2002
- 2001
- 2000
Top applicants under product code IKN
Recent clearances under product code IKN
- K172743 — Natus VikingQuest
- K163150 — ViMove2
- K162383 — Cadwell Sierra Summit, Cadwell Sierra Ascent
- K142494 — ViMove
- K131094 — VIMOVE
- K123902 — PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)
- K123399 — MYOVISION 3.0 WIREFREE SYSTEM
- K113074 — CMAP PRO
- K102610 — FOCUS EMG DEVICE
- K110048 — CERSR ELECTROMYOGRAPHY SYSTEM
- K083679 — UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1
- K073415 — NEMUS SYSTEM; NEMUS PC PERIPHERAL
- K063447 — INSIGHT DISCOVERY
- K052112 — XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059
- K031995 — COMPREHENSIVE NEUROMUSCULAR PROFILER
- K033452 — CWAS 1000
- K023209 — INSIGHT MILLENNIUM III
- K024316 — NIM-PRS
- K023147 — ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4
- K022719 — PHYSICAL MONITORING REGISTRATION UNIT
- K010590 — NEUROPACK MICRO, MODEL MED-9100A SERIES
- K002104 — COMBINED PHYSIOLOGICAL MONITORING SYSTEM
- K001800 — ACCUWARM EMG HEAT LAMP
- K001562 — NEURO SCAN MEDICAL SYSTEMS A4000
- K000812 — NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE)
- K000220 — MA-300 ELECTROMYOGRAPHY SYSTEM
- K993878 — JE 2000
- K990766 — CERSR ELECTROMYOGRAPHY SYSTEM
- K984052 — SYNERGY IOM SYSTEM
- K972419 — TOENNIES NEUROSCREEN SYSTEM
- K974385 — MLS ELECTROMYOGRAPHIC PREAMPLIFIER
- K974010 — ADVANTAGE EMG SYSTEM, MODEL #A100
- K973355 — ADVANTAGE 3000
- K941144 — EXCEL EMG
- K942965 — COMPUTER DYNO/GONIO/MYO GRAPHY
- K952655 — B & L ELECTRODE
- K944787 — INTEGRATED MOVEMENT ANALYZER
- K935368 — STC DIAGNOSTIC 8000
- K930328 — NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT
- K922488 — PHASIS ELECTROMYOGRAPH
- K911388 — CAVOMAT
- K901732 — EMG ACCESSORY FOR POSTUROGRAPHY
- K912071 — SPACE(TM) 7500
- K893130 — EMG NAVIGATOR & EMG TRAVELER
- K883781 — NICOLET NEUROPORT/ACE SYSTEM
- K890495 — NICOLET VIKING II SYSTEM
- K880976 — AL-200B MUSCLE ACTIVITY INTEGRATOR
- K880977 — ADR-2000 AMBULATORY DATA RECORDING SYSTEM
- K880573 — MODIFIED NICOLET VIKING SYSTEM
- K872836 — SPINOSCOPE
- K864660 — MODEL M402 EMG MONITOR
- K864408 — EMG-1, MOTOR NERVE MONITOR
- K864641 — VENTEX-IA
- K864630 — KC/EMG DIAGNOSTIC ELECTROMYOGRAPH
- K862236 — MYOLAB II, MODEL ML-200
- K853804 — VICON (MODIFICATION)
- K842649 — BATH TUB TRANSFER CHAIR
- K842956 — NICOLET VIKING
- K842611 — CA2000
- K842612 — COMPACT AUDITORY
- K842613 — COMPACT VISUAL
- K833927 — ELECTRO-MYOSCOPE 85
- K830702 — NICOLET EMG SATELLITE
- K823562 — EMG MODULES FOR POLYGRAPH SYSTEM
- K822624 — O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381
- K821910 — ANESTHESIA & BRAIN MONITOR
- K821237 — NEUROMATIC 2000
- K812715 — TECA #TE 8
- K802637 — TECA MODEL-10 ELECTROMYOGRAPH
- K800648 — CADWELL 7200
- K791235 — CADWELL 7000 ELECTROMYOGRAPH MACHINE
- K790664 — MODEL 1309 AUDIO MONITOR
- K781399 — TECA MODEL B9 ELECTROMYOGRAPH
- K780541 — PRESSURE MODULES MODELS 1855 & 1856
- K772005 — MYOTONE EMG MONITOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.