Clearance Summary
HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P received FDA 510(k) clearance under submission number K102236, sponsored by D.T. Davis Enterprises Ltd. T/A Hovertech Int'L. 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 2010-11-18.
- Submission: K102236
- Applicant / Sponsor: D.T. Davis Enterprises Ltd. T/A Hovertech Int'L
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3690
- Decision date: 2010-11-18
Classification & Regulation
This clearance is catalogued under FDA product code INK and 21 CFR 890.3690, within the Physical Medicine review panel as a Class II device.