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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Breast, Powered
510(k) Number K252744
Device Name Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)
Applicant
Cixi Ruihong Electric Appliance Co., Ltd.
#18, Xiamaojia Rd., Shuangqingpu Village
Xinpu Town, Cixi, Ningbo, 315322, Zhejiang, China
Cixi,  CN 315322
Applicant Contact Feng Liu
Correspondent
Grzan Medical Technology (Shenzhen) Co., Ltd.
Rm. 103-108, 1st Floor, Block B, Bldg. 2
Bangkai Science And Tech Park, Guanguang Rd., Guangming Dist
Shenzhen,  CN 518107
Correspondent Contact Garen Liu
Regulation Number884.5160
Classification Product Code
HGX  
Date Received08/29/2025
Decision Date 04/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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