IKT · Electrode, Needle, Diagnostic Electromyograph
Physical Medicine · 21 CFR 890.1385 · Class 2
Overview
| Product Code | IKT |
|---|---|
| Device Name | Electrode, Needle, Diagnostic Electromyograph |
| Regulation | 21 CFR 890.1385 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
Identification
A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 43)
Showing 20 most recent of 43 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253581 | 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) | Technomed Europe | Mar 15, 2026 | SESE |
| K173815 | Allergan Botox Needle Electrode | Natus Manufacturing Limited | Jun 29, 2018 | SESE |
| K161430 | Myoject Luer Lock Needle Electrode | Natus Manufacturing Limited | Mar 2, 2017 | SESE |
| K152984 | Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes | Bio Protech, Inc. | Jun 3, 2016 | SESE |
| K143433 | Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm | Natus Manufacturing Limited | Aug 28, 2015 | SESE |
| K120342 | EMG RECORDING ELECTRODE ASSEMBLY | Rhythmlink International, LLC | Jun 22, 2012 | SESE |
| K112034 | TECA ELITE DISPOSABLE CONCENTRIC NEEDLES | Carefusion 209, Inc. | Aug 12, 2011 | SESE |
| K111131 | TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES | Carefusion 209, Inc. | Jun 17, 2011 | SESE |
| K092973 | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE | Bionen S.A.S. | Oct 7, 2010 | SESE |
| K093825 | AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE | Ambu A/S | Jan 13, 2010 | SESE |
| K091410 | DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, | Spes Medica Srl | Aug 11, 2009 | SESE |
| K091056 | RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R | Rhythmlink International, LLC | Jun 23, 2009 | SESE |
| K091055 | RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R | Rhythmlink International, LLC | Jun 23, 2009 | SESE |
| K080914 | ULTRASHARP CONCENTRIC NEEDLES | Rochester Electro Medical, Inc. | Jul 15, 2008 | SESE |
| K071186 | MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE | Ambu A/S | Jul 30, 2007 | SESE |
| K062437 | DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED | Technomed Europe | Feb 16, 2007 | SESE |
| K020907 | NEUROLINE, SUBDERMAL NEEDLE ELECTRODES | Medicotest A/S | Jun 14, 2002 | SESE |
| K011818 | STERILE EMG ELECTRODES | Nicolet Biomedical, Inc. | Sep 6, 2001 | SESE |
| K002992 | DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431 | Medtronic Functional Diagnostics A/S | Aug 15, 2001 | SESE |
| K001869 | DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE | Medicotest A/S | Sep 18, 2000 | SESE |
Top Applicants
- Chalgren Enterprises, Inc. — 9 clearances
- Dantec Medical, Inc. — 3 clearances
- Medicotest A/S — 3 clearances
- Natus Manufacturing Limited — 3 clearances
- Rhythmlink International, LLC — 3 clearances
