K-number	K193364
Device name	Intimate Rose Kegel Exercise System
Applicant	Plus EV Holdings Dba Intimate Rose
Product code	HIR
Device class	Class II
Decision date	Aug 24, 2020
Decision	Substantially Equivalent
Regulation	884.1425

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Source

View the full FDA submission: accessdata.fda.gov

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Intimate Rose Kegel Exercise System

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