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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 -0874
Applicant Contact STECKER, PHD
Correspondent
HEALTHDIRECTIONS, INC.
POST OFFICE BOX 874
MORRISVILLE,  PA  19067 -0874
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
Recalls CDRH Recalls
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