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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 K193364
Device Name Intimate Rose Kegel Exercise System
Applicant
Plus EV Holdings Dba Intimate Rose
1700 Iron St.
North Kansas City,  MO  64116
Applicant Contact Aaron Wilt
Correspondent
Q-Metrics, LLC
860 Lindenwood Ln.
Medina,  OH  44256
Correspondent Contact Elizabeth Proctor
Regulation Number884.1425
Classification Product Code
HIR  
Date Received12/04/2019
Decision Date 08/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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