Clearance Summary
TE-800 PELVIC FLOOR EXERCISER received FDA 510(k) clearance under submission number K945937, sponsored by Myo/Kinetic Systems, Inc.. 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 1995-07-14.
- Submission: K945937
- Applicant / Sponsor: Myo/Kinetic Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1425
- Decision date: 1995-07-14
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.