# K062437: Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private Labeled

- Pathway: 510(k) (Traditional)
- Applicant: Technomed Europe
- Decided: Feb 16, 2007 after 189 days
- Product code: IKT (Electrode, Needle, Diagnostic Electromyograph)
- Device class: 2
- Regulation: 21 CFR 890.1385
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973444 (1997). 2 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973444: Teca Myoject Disposable Needle Electrodes, Medelec, Inc. D.B.A. Teca Corp. (1997) Summary page 1.
- K002992: Disposable Hypodermic Needle Electrode, Model 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431, Medtronic Functional Diagnostics A/S (2001) Summary page 1.

## Most influential descendants
- K130136: Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes, (2013), 3 descendants of its own
- K091410: Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot, (2009), 2 descendants of its own
- K092973: Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar Needle (2010), 1 descendant of its own
- K241045: Disposable Subdermal Needle Electrode, Corkscrew (2024), 0 descendants of its own
- K161566: DMS Disposable Subdermal Needle Electrodes (2016), 0 descendants of its own

## Indications for use
The disposable hypodermic EMG needle electrode is used for muscle stimulation, motor unit action potential recording and drug delivery. The motQr nerves are monitored by detecting EMG activity in the muscles they innervate. The drug used should be Botox Botilium Toxin type A. Note: Technomed Europe does not supply any drugs with the Disposable hypodermic EMG needle electrodes nor does Technomed Europe offer for sale any form of drugs.

Source page: https://510kreport.com/device/K062437
Methodology: https://510kreport.com/methodology