Electrode, Needle, Diagnostic Electromyograph
FDA product code IKT · Class II (moderate risk) · 21 CFR 890.1385 · Physical Medicine
43510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Chalgren Enterprises, Inc. 9
- Dantec Medical, Inc. 3
- Natus Manufacturing Limited 3
- Medicotest A/S 3
- Technomed Europe 3
- Rhythmlink International, LLC 3
- Nihon Kohden America, Inc. 2
- Carefusion 209, Inc. 2
- Medelec, Inc. D.B.A. Teca Corp. 2
- Medtronic Functional Diagnostics A/S 2
- Ambu A/S 2
- Bio Protech, Inc. 1
- Bionen S.A.S. 1
- Spes Medica Srl 1
- Rochester Electro Medical, Inc. 1
- Nicolet Biomedical, Inc. 1
- Specialized Laboratory Equipment, Ltd. 1
- Medelec Intl. Corp. 1
- The Electrode Store, Inc. 1
- Dantec Electronics, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253581 | Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable…IKT · Traditional | Technomed Europe | 03/15/2026SE |
| K173815 | Allergan Botox Needle ElectrodeIKT · Traditional | Natus Manufacturing Limited | 06/29/2018SE |
| K161430 | Myoject Luer Lock Needle ElectrodeIKT · Traditional | Natus Manufacturing Limited | 03/02/2017SE |
| K152984 | Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…IKT · Traditional | Bio Protech, Inc. | 06/03/2016SE |
| K143433 | Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable…IKT · Traditional | Natus Manufacturing Limited | 08/28/2015SE |
| K120342 | Emg Recording Electrode AssemblyIKT · Traditional | Rhythmlink International, LLC | 06/22/2012SE |
| K112034 | Teca Elite Disposable Concentric NeedlesIKT · Special | Carefusion 209, Inc. | 08/12/2011SE |
| K111131 | Teca (TM) Elite Disposable Monopolar NeedlesIKT · Special | Carefusion 209, Inc. | 06/17/2011SE |
| K092973 | Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar NeedleIKT · Traditional | Bionen S.A.S. | 10/07/2010SE |
| K093825 | Ambu Neuroline Disposable Inoject Needle ElectrodeIKT · Special | Ambu A/S | 01/13/2010SE |
| K091410 | Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,IKT · Traditional | Spes Medica Srl | 08/11/2009SE |
| K091056 | Rhythmlink Disposable Monopolar Emg Needle, Model TFDN26032252RIKT · Traditional | Rhythmlink International, LLC | 06/23/2009SE |
| K091055 | Rhythmlink Disposable Concentric Emg Needle, Model D039032252RIKT · Traditional | Rhythmlink International, LLC | 06/23/2009SE |
| K080914 | Ultrasharp Concentric NeedlesIKT · Abbreviated | Rochester Electro Medical, Inc. | 07/15/2008SE |
| K071186 | Modification to: Ambu Neuroline Concentric Needle ElectrodeIKT · Traditional | Ambu A/S | 07/30/2007SE |
| K062437 | Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private LabeledIKT · Traditional | Technomed Europe | 02/16/2007SE |
| K020907 | Neuroline, Subdermal Needle ElectrodesIKT · Traditional | Medicotest A/S | 06/14/2002SE |
| K011818 | Sterile Emg ElectrodesIKT · Abbreviated | Nicolet Biomedical, Inc. | 09/06/2001SE |
| K002992 | Disposable Hypodermic Needle Electrode, Model 9013S0421,9013S0431,9013S0441,9013S0451,901…IKT · Traditional | Medtronic Functional Diagnostics A/S | 08/15/2001SE |
| K001869 | Diagnostic Electromyography Needle Electrode, Disposable Hypodermic NeedleIKT · Traditional | Medicotest A/S | 09/18/2000SE |
| K982950 | Fine Wire Electrode Mmodel Numbers 221-14-730, 221-24-730, 221-14-550, 221-24-550IKT · Traditional | Chalgren Enterprises, Inc. | 06/22/1999SE |
| K990015 | Electrode NeedlesIKT · Traditional | Technomed Europe | 05/27/1999SE |
| K990375 | Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75IKT · Special | Medtronic Functional Diagnostics A/S | 03/09/1999SE |
| K981004 | Sle Emg Electrodes and AccessoriesIKT · Traditional | Specialized Laboratory Equipment, Ltd. | 10/21/1998SE |
| K973529 | Neuroline, Disposable Concentric Needle ElectrodesIKT · Traditional | Medicotest A/S | 11/20/1997SE |
| K973444 | Teca Myoject Disposable Needle ElectrodesIKT · Traditional | Medelec, Inc. D.B.A. Teca Corp. | 11/20/1997SE |
| K973442 | Teca Disposable Monopolar Needle ElectrodesIKT · Traditional | Medelec, Inc. D.B.A. Teca Corp. | 11/20/1997SE |
| K961013 | Disposable Needle ElectrodeIKT · Traditional | Medelec Intl. Corp. | 12/20/1996SE |
| K960591 | Re-Usable Bipolar Concentric NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STPIKT · Traditional | Chalgren Enterprises, Inc. | 06/13/1996SE |
| K955335 | Disposable Hypodermic Monopolar Needle Recording ElectrodeIKT · Traditional | Chalgren Enterprises, Inc. | 01/29/1996SE |
| K932691 | Protectrode Systems ConcentricIKT · Traditional | The Electrode Store, Inc. | 11/16/1995SE |
| K953887 | Re-Usable Concentric NeedleIKT · Traditional | Chalgren Enterprises, Inc. | 10/31/1995SE |
| K953886 | Re-Usable Monopolar NeedleIKT · Traditional | Chalgren Enterprises, Inc. | 10/31/1995SE |
| K932059 | Needle Electrodes and Disposable Scalp ElectrodeIKT · Traditional | Dantec Medical, Inc. | 10/04/1994SE |
| K931029 | Disposable Concentric Needle ElectrodeIKT · Traditional | Chalgren Enterprises, Inc. | 08/25/1994SE |
| K931966 | Dantec Disposable Concentric NeedleIKT · Traditional | Dantec Medical, Inc. | 03/30/1994SE |
| K924521 | Disposable Concentric Needle ElectrodeIKT · Traditional | Chalgren Enterprises, Inc. | 02/12/1993SE |
| K912283 | Detachable, Disposable Monopolar Needle ElectrodeIKT · Traditional | Chalgren Enterprises, Inc. | 03/16/1992SE |
| K912282 | Disposable Monopolar Needle Electrode, Var ModelsIKT · Traditional | Chalgren Enterprises, Inc. | 03/16/1992SE |
| K896874 | Dantec Electrodes Model Dne 116, 117 & 13P02/12IKT · Traditional | Dantec Medical, Inc. | 06/18/1990SE |
| K895460 | Concentric Electrode Type #13R01, 13R02IKT · Traditional | Dantec Electronics, Inc. | 06/18/1990SE |
| K870795 | Emg Electrodes and Extension CordsIKT · Traditional | Nihon Kohden America, Inc. | 03/13/1987SE |
| K854664 | MEB-5200IKT · Traditional | Nihon Kohden America, Inc. | 08/14/1986SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1737-2022 Class II | Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25…Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result… | Technomed Europe | 08/09/2022Terminated |
| Z-2446-2010 | Disposable Detachable Monopolar Needle Electrode for electromyograph model number…Sterility Compromised-- Investigation found that individual packaging seals were separating, which may… | Chalgren Enterprises Inc | 04/12/2007Terminated |