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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 K141893
Device Name VIBRANCE KEGEL DEVICE (VKD)
Applicant
Bioinfinity (M) Sdn. Bhd.
816 Congress Ave. Suite 1400
Austin,  TX  78701
Applicant Contact Carrie Hetrick
Correspondent
Bioinfinity (M) Sdn. Bhd.
816 Congress Ave. Suite 1400
Austin,  TX  78701
Correspondent Contact Carrie Hetrick
Regulation Number884.1425
Classification Product Code
HIR  
Date Received07/14/2014
Decision Date 12/18/2014
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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