Clearance Summary
ATHENA PELVIC MUSCLE TRAINER received FDA 510(k) clearance under submission number K023905, sponsored by Athena Feminine Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2003-04-30.
- Submission: K023905
- Applicant / Sponsor: Athena Feminine Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5320
- Decision date: 2003-04-30
Classification & Regulation
This clearance is catalogued under FDA product code KPI and 21 CFR 876.5320, within the Gastroenterology, Urology review panel as a Class II device.