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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 K200409
Device Name Pelvital System
Applicant
Pelvital USA, Inc.
1000 Lasalle Ave., Sch 435
Minneapolis,  MN  55403
Applicant Contact Dale Wahlstrom
Correspondent
Hetrick Medical Device Consulting, LLC
19123 W. 60th Ln.
Golden,  CO  80403
Correspondent Contact Carrie Hetrick
Regulation Number884.1425
Classification Product Code
HIR  
Date Received02/19/2020
Decision Date 07/10/2020
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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