Clearance Summary
KING I POWERED SCOOTER, MODEL CTL-11 received FDA 510(k) clearance under submission number K052673, sponsored by King I Tech Corporation. 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 2005-10-17.
- Submission: K052673
- Applicant / Sponsor: King I Tech Corporation
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3800
- Decision date: 2005-10-17
Classification & Regulation
This clearance is catalogued under FDA product code INI and 21 CFR 890.3800, within the Physical Medicine review panel as a Class II device.