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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K250227
Device Name JOVS Electric Stimulation Beauty Device (JE2)
Applicant
Shenzhen Qianyu Technology Co., Ltd.
Rm. 601, Han'S Technology Center, #9988, Shennan Ave.
Maling Community,Yuehai St., Nanshan District
Shenzhen City,  CN 518000
Applicant Contact Guoyang Li
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center
# 3101-90, Qianhai Rd.
Shenzhen,  CN 518000
Correspondent Contact Tracy Che
Regulation Number882.5890
Classification Product Code
NFO  
Date Received01/27/2025
Decision Date 10/17/2025
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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