# K883812: HP-1 (Healthpax)

- Pathway: 510(k) (Traditional)
- Applicant: Healthdirections, Inc.
- Decided: Nov 28, 1988 after 81 days
- Product code: QJQ (Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety)
- Device class: 2
- Regulation: 21 CFR 882.5800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K062284: Ces Ultra (2007), 4 descendants of its own
- K230826: Modius Sleep (2023), 1 descendant of its own
- K252951: Genesis Sleep (2025), 0 descendants of its own
- K232253: Modius Stress (2024), 0 descendants of its own
- K182311: Cervella (2019), 0 descendants of its own

## Recalls of this device
- Jul 19, 2007 · Not classified · Z-1242-2007: Peak voltage test result not in acceptable limits.

Source page: https://510kreport.com/device/K883812
Methodology: https://510kreport.com/methodology