Jmoon Conductive Gel

FDA 510(k) K243749 · Shenzhen Ulike Smart Electronics Co., Ltd.

Substantially Equivalent

510(k) numberK243749

Submission

Device name
Jmoon Conductive Gel
Applicant
Shenzhen Ulike Smart Electronics Co., Ltd.
Shenzhen, CN
Received
December 5, 2024
Decision date
April 8, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GYB – Media, Electroconductive
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1275
Specialty
Neurology

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Questions and answers

When was Jmoon Conductive Gel cleared by the FDA?

Jmoon Conductive Gel (K243749) received a 510(k) decision of Substantially Equivalent on April 8, 2025, 124 days after the submission was received.

What is the product code of K243749?

The FDA product code is GYB – Media, Electroconductive, a Class II (moderate risk) device regulated under 21 CFR 882.1275.