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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K891693
Device Name AUTOMATED THERAPY SYSTEM
Applicant
Harding & Harris, Inc.
P.O. Box 1599
Orem,  UT  84059
Applicant Contact DOUGLAS HARDING
Correspondent
Harding & Harris, Inc.
P.O. Box 1599
Orem,  UT  84059
Correspondent Contact DOUGLAS HARDING
Regulation Number882.5050
Classification Product Code
HCC  
Date Received03/22/1989
Decision Date 08/21/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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