Cleared Traditional

Jmoon Conductive Gel

K243749 · Shenzhen Ulike Smart Electronics Co., Ltd. · Neurology

Apr 2025

Decision

124d

Days

Class 2

Risk

About This 510(k) Submission

K243749 is an FDA 510(k) clearance for the Jmoon Conductive Gel, a Media, Electroconductive (Class II — Special Controls, product code GYB), submitted by Shenzhen Ulike Smart Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 8, 2025, 124 days after receiving the submission on December 5, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1275.

Submission Details

510(k) Number	K243749 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	GYB — Media, Electroconductive
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1275

Manufacturer

Shenzhen Ulike Smart Electronics Co., Ltd.

Shenzhen · CN

Yang Blue

20 submissions 20 cleared

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