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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Electroconductive
510(k) Number K243749
Device Name Jmoon Conductive Gel
Applicant
Shenzhen Ulike Smart Electronics Co., Ltd.
810, Bldg. 1, Xunmei Science And Technology Plz.
# 8 Keyuan Rd., Science Park Community
Shenzhen,  CN
Applicant Contact Yang Blue
Correspondent
Shenzhen Ulike Smart Electronics Co., Ltd.
810, Bldg. 1, Xunmei Science And Technology Plz.
# 8 Keyuan Rd., Science Park Community
Shenzhen,  CN
Correspondent Contact Yang Blue
Regulation Number882.1275
Classification Product Code
GYB  
Date Received12/05/2024
Decision Date 04/08/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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