FDA.reportPublic FDA data

510(k) K253581

Device
Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)
Applicant
Technomed Europe
510(k) number
K253581
Product code
IKT
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-15
Date received
2025-11-17
Regulation
890.1385
Classification name
Electrode, Needle, Diagnostic Electromyograph
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Alan Yik
Address
Wiebachstraat 25a Kerkrade NL 6466 NG 6466 NG

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IKT#

510(k), Device, Applicant table
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K120342EMG RECORDING ELECTRODE ASSEMBLYRhythmlink International, LLC2012-06-22
K112034TECA ELITE DISPOSABLE CONCENTRIC NEEDLESCarefusion 209, Inc.2011-08-12
K111131TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLESCarefusion 209, Inc.2011-06-17
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K093825AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODEAmbu A/S2010-01-13
K091410DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,Spes Medica Srl2009-08-11
K091055RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252RRhythmlink International, LLC2009-06-23
K091056RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252RRhythmlink International, LLC2009-06-23
K080914ULTRASHARP CONCENTRIC NEEDLESRochester Electro Medical, Inc.2008-07-15
K071186MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODEAmbu A/S2007-07-30
K062437DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELEDTechnomed Europe2007-02-16