510(k) K243749
K243749 is an FDA 510(k) premarket notification submitted by Shenzhen Ulike Smart Electronics Co., Ltd. for the device "Jmoon Conductive Gel". The FDA issued a decision of Substantially Equivalent on April 8, 2025. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. Shenzhen Ulike Smart Electronics Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 2025
- Date Received
- December 5, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Electroconductive
- Device Class
- Class II
- Regulation Number
- 882.1275
- Review Panel
- NE
- Submission Type