Cleared Traditional

K063402 - WICK ELECTRODE, MODEL M019260

K063402 is an FDA 510(k) clearance for WICK ELECTRODE, manufactured by Intelligent Hearing Systems. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K063402 · Intelligent Hearing Systems · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
32d
Days
Class 2
Risk

K063402 is an FDA 510(k) clearance for the WICK ELECTRODE, MODEL M019260. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Intelligent Hearing Systems (Miami, US). The FDA issued a Cleared decision on December 11, 2006 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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.

FDA 510(k) Submission Details - K063402

510(k) Number K063402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2006
Decision Date December 11, 2006
Days to Decision 32 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 149d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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.

Regulatory Peers - GXY Electrode, Cutaneous

All 378
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K063402.
GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES
K062675 · Gemore Technology Co, Ltd. · Jan 2007
SUNSPOTS PRE-GELLED SURFACE ELECTRODES
K062198 · Axon Systems, Inc. · Dec 2006
BIS BILATERAL SENSOR
K062692 · Aspect Medical Systems, Inc. · Dec 2006
XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES
K061269 · Excel Tech. , Ltd. · Aug 2006
INSPIRSTAR GLOVE ELECTRODE
K061343 · Inspirstar, Inc. · May 2006
RHYTHMLINK DISC ELECTRODES
K061148 · Rhythmlink International, LLC · May 2006
K063402 · WICK ELECTRODE, MODEL M019260
Download PDF FDA Summary Intelligent Hearing S…