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
49–72 of 172
Cleared May 17, 1985
HR/BVP 100T HEART RATE MONITOR
K850643
Thought Technology , Ltd.
Neurology · 87d
Cleared Jan 30, 1984
CALMTONE
K834519
Thought Technology , Ltd.
Neurology · 40d
Cleared Dec 03, 1982
CALMSET 3 TM
K823146
Thought Technology , Ltd.
Neurology · 39d
Cleared Oct 08, 1982
EMG 100T
K822814
Thought Technology , Ltd.
Neurology · 18d
Cleared Aug 25, 1981
LIFE-TECH #1753 BIOFEEDBACK TRAINER
K812179
Life-Tech Instruments, Inc.
Neurology · 22d
Cleared May 18, 1981
SC/TEMP 300
K810332
Thought Technology , Ltd.
Neurology · 98d