HP-1 (HEALTHPAX)— 510(k) K883812

Substantially Equivalent

Healthdirections, Inc.

FDA 510(k) clearance K883812 for HP-1 (HEALTHPAX), Substantially Equivalent on 1988-11-28. Applicant: Healthdirections, Inc.. Device class: 2.

Clearance details

Applicant: Healthdirections, Inc.
Product code: Code QJQ
Device class: Class 2
Regulation: 21 CFR 882.5800
Advisory panel: Neurology
Date received: 1988-09-08
Decision date: 1988-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QJQ

K252951 — Genesis Sleep2025-12-31
K232253 — Modius Stress2024-03-27
K230826 — Modius Sleep2023-10-27
K182311 — Cervella2019-03-07
K090052 — CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C2009-05-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.