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510(k) K883812

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

K883812 is an FDA 510(k) premarket notification submitted by Healthdirections, Inc. for the device "HP-1 (HEALTHPAX)". The FDA issued a decision of Substantially Equivalent on Nov 28, 1988. The device falls under product code QJQ (Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety), a Class II device regulated under 21 CFR 882.5800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 28, 1988
Date Received
Sep 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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  • K230826 — Modius Sleep (Oct 27, 2023)
  • K182311 — Cervella (Mar 7, 2019)
  • K090052 — CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C (May 29, 2009)
  • K070412 — ELEXOMA MEDIC (May 21, 2008)
  • K062284 — CES ULTRA (Apr 5, 2007)
  • K060158 — NET-2000 MICROCURRENT STIMULATOR (Oct 13, 2006)
  • K024377 — TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1 (Jul 21, 2003)
  • K932050 — NH-2002 (Jun 5, 1995)

FDA data resources