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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 149d · 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 Consultant

Tuv Sud America, Inc.
LAURA DANIELSON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GXY Electrode, Cutaneous

All 344
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K070612.
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