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
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Device, Biofeedback Devices (Product Code HCC)

172 devices
1–24 of 172
Cleared Aug 01, 2024
A Breathing System (ABS)
K233580
Deepwell Dtx, Inc.
Neurology · 268d
Cleared Mar 17, 2023
Prism
K222101
Graymatters Health , Ltd.
Neurology · 242d
Cleared Aug 23, 2018
Freespira
K180173
Palo Alto Health Sciences, Inc.
Neurology · 213d
Cleared Sep 01, 2017
GrindCare System
K163448
Sunstar Suisse S.A.
Neurology · 267d
Cleared Dec 22, 2015
Pacifier Activated Lullaby (PAL®)
K151050
Power Medical Devices, LLC
Neurology · 246d
Cleared Sep 09, 2015
NFANT Feeding Solution
K143507
Nfant Labs, LLC
Neurology · 273d
Cleared Dec 10, 2013
CANARY BREATHING SYSTEM
K131586
Palo Alto Health Sciences, Inc.
Neurology · 193d
Cleared Feb 06, 2013
EEGER4 MODEL 4.3
K122879
Eeg Software, LLC
Neurology · 140d
Cleared Sep 29, 2011
EMG SYSTEM
K111687
Myotronics-Noromed, Inc.
Neurology · 105d
Cleared Aug 12, 2004
POLYGRAM NET BIOFEEDBACK APPLICATION
K041244
Medtronic Vascular
Neurology · 93d
Cleared Dec 11, 2001
SONDREX P.A.L. SYSTEM
K010388
Ohmeda Medical
Neurology · 306d
Cleared Oct 15, 2001
EAR MUFFINS
K012384
Bio-Logic Systems Corp.
Neurology · 80d
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

About Product Code HCC - Regulatory Context

510(k) Submission Activity

172 total 510(k) submissions under product code HCC since 1976, with 172 receiving FDA clearance (average review time: 176 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.