Cleared Traditional

DR-HO'S Electro Therapy Conductive Gel (K200402) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200402 · Guangzhou Xinbo Electronic Co., Ltd. · Neurology device
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Nov 2020
Decision
280d
Days
Class 2
Risk

K200402 is an FDA 510(k) clearance for the DR-HO'S Electro Therapy Conductive Gel. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Guangzhou Xinbo Electronic Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on November 25, 2020 after a review of 280 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1275 - 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 Guangzhou Xinbo Electronic Co., Ltd. devices

Submission Details

510(k) Number K200402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2020
Decision Date November 25, 2020
Days to Decision 280 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
132d slower than avg
Panel avg: 148d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GYB Media, Electroconductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1275
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 GLOMED Biological Technology Co., Ltd.
Cassie Lee

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 - GYB Media, Electroconductive

All 13
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K200402.
EEG-acp
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AC Cream - Conductive paste
K212326 · Spes Medica Srl · Dec 2021
GT5 conductive & abrasive gel
K212787 · Wuhan Greentek Pty , Ltd. · Nov 2021
Elefix V Paste for EEG & EMG
K191975 · Nihon Kohden Corporation · Feb 2020
SAC2 - Electrode Cream
K192606 · Spes Medica Srl · Jan 2020
Tech Dots - Adhesive and conductive gel
K190050 · Spes Medica Srl · Jul 2019