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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Perineometer
510(k) Number K252748
Device Name Pelvic Floor Exerciser (PF01)
Applicant
Hunan Accurate Bio-Medical Technology Co., Ltd.
Accurate Industrial Park, #108, Zhixian Rd.
Xuelian Community, Xueshi St. Of Yuelu District
Changsha,  CN 410208
Applicant Contact Li Zhang
Correspondent
Hunan Accurate Bio-Medical Technology Co., Ltd.
Accurate Industrial Park, #108, Zhixian Rd.
Xuelian Community, Xueshi St. Of Yuelu District
Changsha,  CN 410208
Correspondent Contact Yanhong Mo
Regulation Number884.1425
Classification Product Code
HIR  
Date Received08/29/2025
Decision Date 04/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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