K102236 is an FDA 510(k) clearance for the HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P. This device is classified as a Stretcher, Wheeled, Powered (Class II - Special Controls, product code INK).
Submitted by D.T. Davis Enterprises Ltd. T/A Hovertech Int'L (Bethlehem, US). The FDA issued a Cleared decision on November 18, 2010, 101 days after receiving the submission on August 9, 2010.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3690.
| 510(k) Number | K102236 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2010 |
| Decision Date | November 18, 2010 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | INK — Stretcher, Wheeled, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3690 |