HCC · Class II · 21 CFR 882.5050

FDA Product Code HCC: Device, Biofeedback

Leading manufacturers include Thought Technology , Ltd., Bio-Feedback Systems, Inc. and Moe.

173
Total
173
Cleared
177d
Avg days
1976
Since
173 devices
25–48 of 173
Cleared Jan 04, 2001
ORION PLATINUM
K003367
Srs Medical Systems, Inc.
Neurology · 66d
Cleared May 17, 2000
INTERCURE LTD. RESPI-LOW
K000405
Intercure , Ltd.
Neurology · 100d
Cleared Jan 27, 2000
NEUROCOMP
K993654
Neurocybernetics
Neurology · 90d
Cleared Aug 13, 1999
NORODYN 8000 SEMG SYSTEM, ND-8000
K992439
Myotronics-Noromed, Inc.
Neurology · 22d
Cleared Jun 03, 1999
INSIGHT MILLENNIUM
K990778
Fasstech
Neurology · 86d
Cleared May 19, 1999
BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE
K990538
Brainmaster
Neurology · 89d
Cleared Apr 29, 1999
THE BAGNOLI-8 EMG SYSTEM
K990356
Delsys, Inc.
Neurology · 83d
Cleared Jan 07, 1999
XYZ SYSTEM
K983550
Bio-Monitoring International Corp.
Neurology · 90d
Cleared Aug 31, 1998
THE BAGNOLI-4 EMG SYSTEM
K981934
Delsys, Inc.
Neurology · 90d
Cleared Aug 07, 1998
SLEEP MANAGEMENT SYSTEM
K981844
Rmp, Inc.
Neurology · 73d
Cleared Apr 29, 1998
ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE
K980373
Ultramind International , Ltd.
Neurology · 89d
Cleared Apr 14, 1998
MUSCLE RESPONSE MONITOR
K971400
Enriching Your Life
Neurology · 364d
Cleared Feb 18, 1998
PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE
K971708
J & J Engineering, Inc.
Neurology · 286d
Cleared Dec 17, 1997
PATHWAY ELECTROMYOGRAPH
K973537
The Prometheus Group
Neurology · 90d
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