K121287 is an FDA 510(k) clearance for the HT-WEDGE. This device is classified as a Lift, Patient, Ac-powered (Class II - Special Controls, product code FNG).
Submitted by D.T. Davis Enterprises Ltd. T/A Hovertech Int'L (Bethlehem, US). The FDA issued a Cleared decision on October 3, 2012, 156 days after receiving the submission on April 30, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5500.
| 510(k) Number | K121287 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2012 |
| Decision Date | October 03, 2012 |
| Days to Decision | 156 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FNG — Lift, Patient, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5500 |