Cleared Traditional

K171381 - Adhesive Electrodes

K171381 is an FDA 510(k) clearance for Adhesive Electrodes, manufactured by Shenzhen Quality Medical Technology Co.,Ltd. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K171381 · Shenzhen Quality Medical Technology Co.,Ltd · Neurology device
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Dec 2017
Decision
216d
Days
Class 2
Risk

K171381 is an FDA 510(k) clearance for the Adhesive Electrodes. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Shenzhen Quality Medical Technology Co.,Ltd (Shenzhen, CN). The FDA issued a Cleared decision on December 13, 2017 after a review of 216 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 Shenzhen Quality Medical Technology Co.,Ltd devices

FDA 510(k) Submission Details - K171381

510(k) Number K171381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2017
Decision Date December 13, 2017
Days to Decision 216 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
67d slower than avg
Panel avg: 149d · This submission: 216d
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 Consultant

Guangzhou Leta Testing Technology Co., Ltd.
Jet Li

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 338
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