Electrode, Needle, Diagnostic Electromyograph

FDA product code IKT · 42 cleared devices

Class 2 Physical Medicine

Regulation: 21 CFR 890.1385
Review panel: NE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1986-08-14 – 2026-03-15

IKT 2026-03-15

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

K number K253581

View details →

IKT 2018-06-29

Allergan Botox Needle Electrode

Applicant Natus Manufacturing Limited

K number K173815

View details →

IKT 2017-03-02

Myoject Luer Lock Needle Electrode

Applicant Natus Manufacturing Limited

K number K161430

View details →

IKT 2016-06-03

Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes

Applicant Bio Protech, Inc.

K number K152984

View details →

IKT 2012-06-22

EMG RECORDING ELECTRODE ASSEMBLY

Applicant Rhythmlink International, LLC

K number K120342

View details →

IKT 2011-08-12

TECA ELITE DISPOSABLE CONCENTRIC NEEDLES

Applicant Carefusion 209, Inc.

K number K112034

View details →

IKT 2011-06-17

TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES

Applicant Carefusion 209, Inc.

K number K111131

View details →

IKT 2010-10-07

DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE

Applicant Bionen S.A.S.

K number K092973

View details →

IKT 2010-01-13

AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE

Applicant Ambu A/S

K number K093825

View details →

IKT 2009-08-11

DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,

Applicant Spes Medica Srl

K number K091410

View details →

IKT 2009-06-23

RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R

Applicant Rhythmlink International, LLC

K number K091056

View details →

IKT 2009-06-23

RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R

Applicant Rhythmlink International, LLC

K number K091055

View details →

IKT 2008-07-15

ULTRASHARP CONCENTRIC NEEDLES

Applicant Rochester Electro Medical, Inc.

K number K080914

View details →

IKT 2007-07-30

MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE

Applicant Ambu A/S

K number K071186

View details →

IKT 2007-02-16

DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED

Applicant Technomed Europe

K number K062437

View details →

IKT 2002-06-14

NEUROLINE, SUBDERMAL NEEDLE ELECTRODES

Applicant Medicotest A/S

K number K020907

View details →

IKT 2001-09-06

STERILE EMG ELECTRODES

Applicant Nicolet Biomedical, Inc.

K number K011818

View details →

IKT 2001-08-15

DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431

Applicant Medtronic Functional Diagnostics A/S

K number K002992

View details →

IKT 2000-09-18

DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE

Applicant Medicotest A/S

K number K001869

View details →

IKT 1999-06-22

FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550

Applicant Chalgren Enterprises, Inc.

K number K982950

View details →

IKT 1999-05-27

ELECTRODE NEEDLES

Applicant Technomed Europe

K number K990015

View details →

IKT 1999-03-09

DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75

Applicant Medtronic Functional Diagnostics A/S

K number K990375

View details →

IKT 1998-10-21

SLE EMG ELECTRODES AND ACCESSORIES

Applicant Specialized Laboratory Equipment, Ltd.

K number K981004

View details →

IKT 1997-11-20

NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES

Applicant Medicotest A/S

K number K973529

View details →

IKT 1997-11-20

TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES

Applicant Medelec, Inc. D.B.A. Teca Corp.

K number K973444

View details →

IKT 1997-11-20

TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES

Applicant Medelec, Inc. D.B.A. Teca Corp.

K number K973442

View details →

IKT 1996-12-20

DISPOSABLE NEEDLE ELECTRODE

Applicant Medelec Intl. Corp.

K number K961013

View details →

IKT 1996-06-13

RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP

Applicant Chalgren Enterprises, Inc.

K number K960591

View details →

IKT 1996-01-29

DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE

Applicant Chalgren Enterprises, Inc.

K number K955335

View details →

IKT 1995-11-16

PROTECTRODE SYSTEMS CONCENTRIC

Applicant The Electrode Store, Inc.

K number K932691

View details →

IKT 1995-10-31

RE-USABLE CONCENTRIC NEEDLE

Applicant Chalgren Enterprises, Inc.

K number K953887

View details →

IKT 1995-10-31

RE-USABLE MONOPOLAR NEEDLE

Applicant Chalgren Enterprises, Inc.

K number K953886

View details →

IKT 1994-10-04

NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE

Applicant Dantec Medical, Inc.

K number K932059

View details →

IKT 1994-08-25

DISPOSABLE CONCENTRIC NEEDLE ELECTRODE

Applicant Chalgren Enterprises, Inc.

K number K931029

View details →

IKT 1994-03-30

DANTEC DISPOSABLE CONCENTRIC NEEDLE

Applicant Dantec Medical, Inc.

K number K931966

View details →

IKT 1993-02-12

DISPOSABLE CONCENTRIC NEEDLE ELECTRODE

Applicant Chalgren Enterprises, Inc.

K number K924521

View details →

IKT 1992-03-16

DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE

Applicant Chalgren Enterprises, Inc.

K number K912283

View details →

IKT 1992-03-16

DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS

Applicant Chalgren Enterprises, Inc.

K number K912282

View details →

IKT 1990-06-18

DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12

Applicant Dantec Medical, Inc.

K number K896874

View details →

IKT 1990-06-18

CONCENTRIC ELECTRODE TYPE #13R01, 13R02

Applicant Dantec Electronics, Inc.

K number K895460

View details →

IKT 1987-03-13

EMG ELECTRODES AND EXTENSION CORDS

Applicant Nihon Kohden America, Inc.

K number K870795

View details →

IKT 1986-08-14

MEB-5200

Applicant Nihon Kohden America, Inc.

K number K854664

View details →