K243749 is an FDA 510(k) clearance for the Jmoon Conductive Gel. This device is classified as 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 FDA review panel. Regulated under 21 CFR 882.1275.
| 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 |
| Product Code | GYB — Media, Electroconductive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1275 |