Home / Device Classification / IKT

IKT — Electrode, Needle, Diagnostic Electromyograph Class II

FDA Device Classification

Classification Details

Product Code
IKT
Device Class
Class II
Regulation Number
890.1385
Submission Type
Review Panel
NE
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253581technomed europeDisposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); DisposableMarch 15, 2026
K173815natus manufacturing limitedAllergan Botox Needle ElectrodeJune 29, 2018
K161430natus manufacturing limitedMyoject Luer Lock Needle ElectrodeMarch 2, 2017
K152984bio protechDisposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes,June 3, 2016
K143433natus manufacturing limitedDantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable CAugust 28, 2015
K120342rhythmlink internationalEMG RECORDING ELECTRODE ASSEMBLYJune 22, 2012
K112034carefusion 209TECA ELITE DISPOSABLE CONCENTRIC NEEDLESAugust 12, 2011
K111131carefusion 209TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLESJune 17, 2011
K092973bionenDISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NOctober 7, 2010
K093825ambuAMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODEJanuary 13, 2010
K091410spes medicaDISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,August 11, 2009
K091055rhythmlink internationalRHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252RJune 23, 2009
K091056rhythmlink internationalRHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252RJune 23, 2009
K080914rochester electro medicalULTRASHARP CONCENTRIC NEEDLESJuly 15, 2008
K071186ambuMODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODEJuly 30, 2007
K062437technomed europeDISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE February 16, 2007
K020907medicotestNEUROLINE, SUBDERMAL NEEDLE ELECTRODESJune 14, 2002
K011818nicolet biomedicalSTERILE EMG ELECTRODESSeptember 6, 2001
K002992medtronic functional diagnosticsDISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013August 15, 2001
K001869medicotestDIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLESeptember 18, 2000