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510(k) K883812

HP-1 (HEALTHPAX) by Healthdirections, Inc. — Product Code QJQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1988
Date Received
September 8, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Device Class
Class II
Regulation Number
882.5800
Review Panel
NE
Submission Type

To provide electrical current to the head to treat insomnia and/or anxiety

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