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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Coupling, Ultrasound
510(k) Number K253255
Device Name Non-Sterile Ultrasound Gel Sterile Ultrasound Gel
Applicant
Foshan Pingchuang Medical Technology Co., Ltd.
Rm. 301, One Of Huaye Rd. #3, Lingang Venture Park
Shunjiang, Beijiaotown, Shunde District
Foshan,  CN 528312
Applicant Contact Anthony Huang
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Sq.
Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Grace Liu
Regulation Number892.1570
Classification Product Code
MUI  
Date Received09/29/2025
Decision Date 06/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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