Cleared Traditional

K150971 - Zekang Self-adhesive Electrode

K150971 is an FDA 510(k) clearance for Zekang Self-adhesive Electrode, manufactured by Jiangsu Zekang 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 134-day FDA review.

K150971 · Jiangsu Zekang Medical Technology Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
134d
Days
Class 2
Risk

K150971 is an FDA 510(k) clearance for the Zekang Self-adhesive Electrode. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Jiangsu Zekang Medical Technology Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on August 25, 2015 after a review of 134 days - within the typical 510(k) review window.

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 Jiangsu Zekang Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K150971

510(k) Number K150971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2015
Decision Date August 25, 2015
Days to Decision 134 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 148d · This submission: 134d
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 K150971.
Electrodes with snap / Electrodes with pigtail
K171722 · Shenzhen Konmed Technology Co., Ltd. · Jan 2018
Electrodes with silver conductive
K171721 · Shenzhen Konmed Technology Co., Ltd. · Jan 2018
MR Conditional Cup Electrode, MR Conditional Webb Electrode
K172503 · Rhythmlink International, LLC · Dec 2017
BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES)
K143506 · Covidien · Apr 2015
ASCEND ELECTRODE
K140586 · Neurometrix, Inc. · Nov 2014
GARMENT ELECTRODES
K141076 · Shenzhen Dongdixin Technology Co., Ltd. · Nov 2014