Clearance Summary
Intimate Rose Kegel Exercise System received FDA 510(k) clearance under submission number K193364, sponsored by Plus EV Holdings Dba Intimate Rose. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2020-08-24.
- Submission: K193364
- Applicant / Sponsor: Plus EV Holdings Dba Intimate Rose
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1425
- Decision date: 2020-08-24
Classification & Regulation
This clearance is catalogued under FDA product code HIR and 21 CFR 884.1425, within the Obstetrics/Gynecology review panel as a Class II device.