HP-1 (HEALTHPAX)

Cranial Electrotherapy Stimulator To Treat Depression

HEALTHDIRECTIONS, INC.

The following data is part of a premarket notification filed by Healthdirections, Inc. with the FDA for Hp-1 (healthpax).

Pre-market Notification Details

Device IDK883812
510k NumberK883812
Device Name:HP-1 (HEALTHPAX)
ClassificationCranial Electrotherapy Stimulator To Treat Depression
Applicant HEALTHDIRECTIONS, INC. POST OFFICE BOX 874 Morrisville,  PA  19067 -0874
ContactStecker, Phd
CorrespondentStecker, Phd
HEALTHDIRECTIONS, INC. POST OFFICE BOX 874 Morrisville,  PA  19067 -0874
Product CodeJXK  
CFR Regulation Number882.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-09-08
Decision Date1988-11-28

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