HCC · Class II · 21 CFR 882.5050

FDA Product Code HCC: Device, Biofeedback

Leading manufacturers include Deepwell Dtx, Inc., Chattanooga Group, Inc. and Ohmeda Medical.

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 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 Sep 26, 1997
EMG RETRAINER
K972487
Chattanooga Group, Inc.
Neurology · 86d

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.