Cleared Traditional

K180773 - Reusable and Self-Adhesive Electrodes

K180773 is the FDA 510(k) clearance for Reusable and Self-Adhesive Electrodes by Shaoxing Dongzhi Electrical Technology Co., Ltd.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K180773 · Shaoxing Dongzhi Electrical Technology Co., Ltd. · Neurology device
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May 2018
Decision
60d
Days
Class 2
Risk

K180773 is an FDA 510(k) clearance for the Reusable and Self-Adhesive Electrodes. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Shaoxing Dongzhi Electrical Technology Co., Ltd. (Shaoxing, CN). The FDA issued a Cleared decision on May 22, 2018 after a review of 60 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 Shaoxing Dongzhi Electrical Technology Co., Ltd. devices

Submission Details

510(k) Number K180773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2018
Decision Date May 22, 2018
Days to Decision 60 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
88d faster than avg
Panel avg: 148d · This submission: 60d
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 Peers - GXY Electrode, Cutaneous

All 141
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