Cleared Traditional

K002219 - WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE

K002219 is an FDA 510(k) clearance for WANDY SELF-ADHESIVE NEUROSTIMULATION EL..., manufactured by Wandy Rubber Industrial Co., Ltd.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K002219 · Wandy Rubber Industrial Co., Ltd. · Neurology device
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Feb 2001
Decision
193d
Days
Class 2
Risk

K002219 is an FDA 510(k) clearance for the WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Wandy Rubber Industrial Co., Ltd. (Shi-Chih, Taipei, TW). The FDA issued a Cleared decision on February 2, 2001 after a review of 193 days - an extended review 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: 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 Wandy Rubber Industrial Co., Ltd. devices

FDA 510(k) Submission Details - K002219

510(k) Number K002219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2000
Decision Date February 02, 2001
Days to Decision 193 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 148d · This submission: 193d
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 221
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K002219.
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