Cleared Traditional

K181234 - Self-adhesive Electrode

K181234 is the FDA 510(k) clearance for Self-adhesive Electrode by Dong Guan OU Kang Electronics Co., Ltd.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K181234 · Dong Guan OU Kang Electronics Co., Ltd. · Neurology device
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Aug 2018
Decision
90d
Days
Class 2
Risk

K181234 is an FDA 510(k) clearance for the Self-adhesive Electrode. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Dong Guan OU Kang Electronics Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on August 7, 2018 after a review of 90 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 Dong Guan OU Kang Electronics Co., Ltd. devices

Submission Details

510(k) Number K181234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2018
Decision Date August 07, 2018
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Shenzhen Joyantech Consulting Co., Ltd.
Field Fu

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

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