HCC · Class II · 21 CFR 882.5050

FDA Product Code HCC: Device, Biofeedback

Leading manufacturers include Thought Technology , Ltd., The Prometheus Group and Delsys, Inc..

172
Total
172
Cleared
176d
Avg days
1976
Since
172 devices
25–48 of 172
Cleared Oct 02, 1997
BIO TROL
K972723
Mindmedia Labs, Inc.
Neurology · 73d
Cleared Sep 26, 1997
EMG RETRAINER
K972487
Chattanooga Group, Inc.
Neurology · 86d
Cleared Jul 10, 1997
MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE
K970051
Smith and Nephew Donjoy, Inc.
Neurology · 184d
Cleared Jun 25, 1997
MODEL ME 300 MUSCLE TESTER
K943535
Regulatory Strategies, Inc.
Neurology · 1070d
Cleared May 19, 1997
MEGA ME 3000 PROFESSIONAL MUSCLE TESTER
K963202
Mega Electronics , Ltd.
Neurology · 277d
Cleared Feb 05, 1997
AT 62 EEG (A.K.A THE A
K965006
Stoelting Co.
Neurology · 51d
Cleared Oct 31, 1996
MRS-2D
K961645
Lexicor Medical Technology, Inc.
Neurology · 185d
Cleared Aug 27, 1996
DEI MODEL 20 EEG
K961718
Discovery Engineering Intl., Inc.
Neurology · 117d
Cleared Aug 07, 1996
PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20
K960761
The Prometheus Group
Neurology · 163d
Cleared Jul 03, 1996
SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE
K954737
J-Tech, Inc.
Neurology · 261d
Cleared Jun 13, 1996
SYNERGY PLUS
K960762
The Prometheus Group
Neurology · 108d
Cleared Apr 17, 1996
AT53 DUAL CHANNEL EMG
K952797
Stoelting Co.
Neurology · 303d
Cleared Mar 14, 1996
DIGITAL CONDUCTANCE METER
K924313
The Jayms Co.
Neurology · 1296d
Cleared Feb 27, 1996
ORALSENSOR
K953257
Cycura Corp.
Neurology · 230d
Cleared Aug 04, 1995
J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS
K945826
Medical Device Inspection Co., Inc.
Neurology · 248d
Cleared Sep 09, 1992
MYOTRAC2
K915858
Thought Technology , Ltd.
Neurology · 257d
Cleared Sep 09, 1992
MYOTRAC/S, MYODAC/S
K915859
Thought Technology , Ltd.
Neurology · 257d
Cleared Mar 26, 1992
MYOTRAC+/S, MYODAC+/S
K913898
Thought Technology , Ltd.
Neurology · 209d
Cleared Feb 12, 1991
FLEXCOMP DSP & PROCOMP
K903497
Thought Technology , Ltd.
Neurology · 193d
Cleared Oct 09, 1990
M(3):MICRO MUSCLE MONITOR
K896409
Thought Technology , Ltd.
Neurology · 336d
Cleared Oct 13, 1989
MYODAC2 BIOFEEDBACK DEVICE
K894840
Thought Technology , Ltd.
Neurology · 85d
Cleared Nov 16, 1988
MYODAC
K883597
Thought Technology , Ltd.
Neurology · 86d
Cleared Sep 26, 1988
MYOTRAC
K881416
Thought Technology , Ltd.
Neurology · 175d
Cleared May 17, 1985
TEMP/SC 200T -SKIN CONDUCTANCE/SKIN TEMP BIOFEEDBA
K850642
Thought Technology , Ltd.
Neurology · 87d