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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
510(k) Number K883812
Device Name HP-1 (HEALTHPAX)
Applicant
Healthdirections, Inc.
Post Office Box 874
Morrisville,  PA  19067
Applicant Contact STECKER, PHD
Correspondent
Healthdirections, Inc.
Post Office Box 874
Morrisville,  PA  19067
Correspondent Contact STECKER, PHD
Regulation Number882.5800
Classification Product Code
QJQ  
Date Received09/08/1988
Decision Date 11/28/1988
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
Recalls CDRH Recalls
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