The following data is part of a premarket notification filed by Healthdirections, Inc. with the FDA for Hp-1 (healthpax).
Device ID | K883812 |
510k Number | K883812 |
Device Name: | HP-1 (HEALTHPAX) |
Classification | Cranial Electrotherapy Stimulator To Treat Depression |
Applicant | HEALTHDIRECTIONS, INC. POST OFFICE BOX 874 Morrisville, PA 19067 -0874 |
Contact | Stecker, Phd |
Correspondent | Stecker, Phd HEALTHDIRECTIONS, INC. POST OFFICE BOX 874 Morrisville, PA 19067 -0874 |
Product Code | JXK |
CFR Regulation Number | 882.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-08 |
Decision Date | 1988-11-28 |