Intimate Rose Kegel Exercise System— 510(k) K193364

Name: FDA 510(k) clearance K193364
Creator: U.S. Food and Drug Administration
Published: 2020-08-24

Substantially Equivalent

Plus EV Holdings Dba Intimate Rose

FDA 510(k) clearance K193364 for Intimate Rose Kegel Exercise System, Substantially Equivalent on 2020-08-24. Applicant: Plus EV Holdings Dba Intimate Rose. Device class: 2.

Clearance details

Applicant: Plus EV Holdings Dba Intimate Rose
Product code: Code HIR
Device class: Class 2
Regulation: 21 CFR 884.1425
Advisory panel: Obstetrics/Gynecology
Date received: 2019-12-04
Decision date: 2020-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Kansas City, MO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.