Cleared Traditional

K243749 - Jmoon Conductive Gel

K243749 is an FDA 510(k) clearance for Jmoon Conductive Gel, manufactured by Shenzhen Ulike Smart Electronics Co., Ltd.. The device is a Class 2 Neurology device with product code GYB cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K243749 · Shenzhen Ulike Smart Electronics Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
124d
Days
Class 2
Risk

K243749 is an FDA 510(k) clearance for the Jmoon Conductive Gel. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Shenzhen Ulike Smart Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 8, 2025 after a review of 124 days - within the typical 510(k) review window.

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 Shenzhen Ulike Smart Electronics Co., Ltd. devices

FDA 510(k) Submission Details - K243749

510(k) Number K243749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2024
Decision Date April 08, 2025
Days to Decision 124 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
24d faster than avg
Panel avg: 148d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYB Device Classification - Class 2, Special Controls

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 Peers - GYB Media, Electroconductive

All 39
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K243749.
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K212787 · Wuhan Greentek Pty , Ltd. · Nov 2021