Cleared Traditional

ENERGEX (K042686) - FDA 510(k) Clearance

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

K042686 · Energex Systems, Inc. · Neurology device
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Jun 2005
Decision
260d
Days
Class 2
Risk

K042686 is an FDA 510(k) clearance for the ENERGEX. Classified as Device, Discharge, Electrostatic (for Pain Relief) (product code NHH), Class II - Special Controls.

Submitted by Energex Systems, Inc. (Washington, US). The FDA issued a Cleared decision on June 16, 2005 after a review of 260 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.5500 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Energex Systems, Inc. devices

Submission Details

510(k) Number K042686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2004
Decision Date June 16, 2005
Days to Decision 260 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 148d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHH Device, Discharge, Electrostatic (for Pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
Definition An Electrostatic Discharge Device Which Applies An Electrostatic Or Coronal Discharge To Or Near A Person's Skin For The Symptomatic Relief Of Pain
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.