Clearance Summary
POWER TOILET ELEVATOR received FDA 510(k) clearance under submission number K880398, sponsored by Med-West, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1988-03-17.
- Submission: K880398
- Applicant / Sponsor: Med-West, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3110
- Decision date: 1988-03-17
Classification & Regulation
This clearance is catalogued under FDA product code INO and 21 CFR 890.3110, within the Physical Medicine review panel as a Class II device.