FDA Product Code
FDA Product Code IKT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.1385
510(k) Clearances — 43 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| 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 | 2026-03-15 | Traditional | PDF ↗ |
| K173815 | Allergan Botox Needle Electrode | Natus Manufacturing Limited | 2018-06-29 | Traditional | PDF ↗ |
| K161430 | Myoject Luer Lock Needle Electrode | Natus Manufacturing Limited | 2017-03-02 | Traditional | PDF ↗ |
| K152984 | Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes | Bio Protech, Inc. | 2016-06-03 | Traditional | PDF ↗ |
| 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 | 2015-08-28 | Traditional | PDF ↗ |
| K120342 | EMG RECORDING ELECTRODE ASSEMBLY | Rhythmlink International, LLC | 2012-06-22 | Traditional | PDF ↗ |
| K112034 | TECA ELITE DISPOSABLE CONCENTRIC NEEDLES | Carefusion 209, Inc. | 2011-08-12 | Special | PDF ↗ |
| K111131 | TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES | Carefusion 209, Inc. | 2011-06-17 | Special | PDF ↗ |
| K092973 | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE | Bionen S.A.S. | 2010-10-07 | Traditional | PDF ↗ |
| K093825 | AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE | Ambu A/S | 2010-01-13 | Special | PDF ↗ |
| K091410 | DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, | Spes Medica Srl | 2009-08-11 | Traditional | PDF ↗ |
| K091056 | RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R | Rhythmlink International, LLC | 2009-06-23 | Traditional | PDF ↗ |
| K091055 | RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R | Rhythmlink International, LLC | 2009-06-23 | Traditional | PDF ↗ |
| K080914 | ULTRASHARP CONCENTRIC NEEDLES | Rochester Electro Medical, Inc. | 2008-07-15 | Abbreviated | PDF ↗ |
| K071186 | MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE | Ambu A/S | 2007-07-30 | Traditional | PDF ↗ |
| K062437 | DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED | Technomed Europe | 2007-02-16 | Traditional | PDF ↗ |
| K020907 | NEUROLINE, SUBDERMAL NEEDLE ELECTRODES | Medicotest A/S | 2002-06-14 | Traditional | PDF ↗ |
| K011818 | STERILE EMG ELECTRODES | Nicolet Biomedical, Inc. | 2001-09-06 | Abbreviated | PDF ↗ |
| K002992 | DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431 | Medtronic Functional Diagnostics A/S | 2001-08-15 | Traditional | PDF ↗ |
| K001869 | DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE | Medicotest A/S | 2000-09-18 | Traditional | PDF ↗ |
| K982950 | FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550 | Chalgren Enterprises, Inc. | 1999-06-22 | Traditional | PDF ↗ |
| K990015 | ELECTRODE NEEDLES | Technomed Europe | 1999-05-27 | Traditional | PDF ↗ |
| K990375 | DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75 | Medtronic Functional Diagnostics A/S | 1999-03-09 | Special | PDF ↗ |
| K981004 | SLE EMG ELECTRODES AND ACCESSORIES | Specialized Laboratory Equipment, Ltd. | 1998-10-21 | Traditional | PDF ↗ |
| K973442 | TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES | Medelec, Inc. D.B.A. Teca Corp. | 1997-11-20 | Traditional | PDF ↗ |
| K973529 | NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES | Medicotest A/S | 1997-11-20 | Traditional | PDF ↗ |
| K973444 | TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES | Medelec, Inc. D.B.A. Teca Corp. | 1997-11-20 | Traditional | PDF ↗ |
| K961013 | DISPOSABLE NEEDLE ELECTRODE | Medelec Intl. Corp. | 1996-12-20 | Traditional | PDF ↗ |
| K960591 | RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP | Chalgren Enterprises, Inc. | 1996-06-13 | Traditional | PDF ↗ |
| K955335 | DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE | Chalgren Enterprises, Inc. | 1996-01-29 | Traditional | PDF ↗ |
| K932691 | PROTECTRODE SYSTEMS CONCENTRIC | The Electrode Store, Inc. | 1995-11-16 | Traditional | PDF ↗ |
| K953887 | RE-USABLE CONCENTRIC NEEDLE | Chalgren Enterprises, Inc. | 1995-10-31 | Traditional | PDF ↗ |
| K953886 | RE-USABLE MONOPOLAR NEEDLE | Chalgren Enterprises, Inc. | 1995-10-31 | Traditional | PDF ↗ |
| K932059 | NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE | Dantec Medical, Inc. | 1994-10-04 | Traditional | PDF ↗ |
| K931029 | DISPOSABLE CONCENTRIC NEEDLE ELECTRODE | Chalgren Enterprises, Inc. | 1994-08-25 | Traditional | PDF ↗ |
| K931966 | DANTEC DISPOSABLE CONCENTRIC NEEDLE | Dantec Medical, Inc. | 1994-03-30 | Traditional | PDF ↗ |
| K924521 | DISPOSABLE CONCENTRIC NEEDLE ELECTRODE | Chalgren Enterprises, Inc. | 1993-02-12 | Traditional | PDF ↗ |
| K912283 | DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE | Chalgren Enterprises, Inc. | 1992-03-16 | Traditional | PDF ↗ |
| K912282 | DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS | Chalgren Enterprises, Inc. | 1992-03-16 | Traditional | PDF ↗ |
| K896874 | DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12 | Dantec Medical, Inc. | 1990-06-18 | Traditional | PDF ↗ |
| K895460 | CONCENTRIC ELECTRODE TYPE #13R01, 13R02 | Dantec Electronics, Inc. | 1990-06-18 | Traditional | PDF ↗ |
| K870795 | EMG ELECTRODES AND EXTENSION CORDS | Nihon Kohden America, Inc. | 1987-03-13 | Traditional | PDF ↗ |
| K854664 | MEB-5200 | Nihon Kohden America, Inc. | 1986-08-14 | Traditional | PDF ↗ |
Product code IKT · Class II · Physical Medicine. Data: openFDA.