IKT · Class II · 21 CFR 890.1385

FDA Product Code IKT: Electrode, Needle, Diagnostic Electromyograph

Leading manufacturers include Chalgren Enterprises, Inc., Dantec Medical, Inc. and Technomed Europe.

43
Total
43
Cleared
192d
Avg days
1986
Since
43 devices
25–43 of 43
Cleared Oct 31, 1995
RE-USABLE CONCENTRIC NEEDLE
K953887
Chalgren Enterprises, Inc.
Neurology · 75d
Cleared Oct 04, 1994
NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE
K932059
Dantec Medical, Inc.
Neurology · 523d
Cleared Aug 25, 1994
DISPOSABLE CONCENTRIC NEEDLE ELECTRODE
K931029
Chalgren Enterprises, Inc.
Neurology · 542d
Cleared Mar 30, 1994
DANTEC DISPOSABLE CONCENTRIC NEEDLE
K931966
Dantec Medical, Inc.
Neurology · 343d
Cleared Feb 12, 1993
DISPOSABLE CONCENTRIC NEEDLE ELECTRODE
K924521
Chalgren Enterprises, Inc.
Neurology · 157d
Cleared Mar 16, 1992
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS
K912282
Chalgren Enterprises, Inc.
Neurology · 293d
Cleared Mar 16, 1992
DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
K912283
Chalgren Enterprises, Inc.
Neurology · 298d
Cleared Jun 18, 1990
DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12
K896874
Dantec Medical, Inc.
Neurology · 192d
Cleared Mar 13, 1987
EMG ELECTRODES AND EXTENSION CORDS
K870795
Nihon Kohden America, Inc.
Neurology · 15d
Cleared Aug 14, 1986
MEB-5200
K854664
Nihon Kohden America, Inc.
Neurology · 267d