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 |