Cleared Traditional

K070612 - TOP-RANK ADHESIVE ELECTRODE

K070612 is an FDA 510(k) clearance for TOP-RANK ADHESIVE ELECTRODE, manufactured by Top-Rank Health Care Equipment Co., Ltd.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K070612 · Top-Rank Health Care Equipment Co., Ltd. · Neurology device
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May 2007
Decision
63d
Days
Class 2
Risk

K070612 is an FDA 510(k) clearance for the TOP-RANK ADHESIVE ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Top-Rank Health Care Equipment Co., Ltd. (Shangyu City, CN). The FDA issued a Cleared decision on May 7, 2007 after a review of 63 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.

View all Top-Rank Health Care Equipment Co., Ltd. devices

FDA 510(k) Submission Details - K070612

510(k) Number K070612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2007
Decision Date May 07, 2007
Days to Decision 63 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 148d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 190
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K070612.
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