Cleared Traditional

HP-1 (HEALTHPAX) (K883812) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K883812 · Healthdirections, Inc. · Neurology device
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Nov 1988
Decision
81d
Days
Class 2
Risk

K883812 is an FDA 510(k) clearance for the HP-1 (HEALTHPAX). Classified as Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety (product code QJQ), Class II - Special Controls.

Submitted by Healthdirections, Inc. (Morrisville, US). The FDA issued a Cleared decision on November 28, 1988 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5800 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Healthdirections, Inc. devices

Submission Details

510(k) Number K883812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1988
Decision Date November 28, 1988
Days to Decision 81 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 148d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5800
Definition To Provide Electrical Current To The Head To Treat Insomnia And/or Anxiety
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.