510(k) K121287
K121287 is an FDA 510(k) premarket notification submitted by D.T. Davis Enterprises Ltd. T/A Hovertech Int'L for the device "HT-WEDGE". The FDA issued a decision of Substantially Equivalent on October 3, 2012. The device falls under product code FNG (Lift, Patient, Ac-Powered), a Class II device regulated under 21 CFR 880.5500. D.T. Davis Enterprises Ltd. T/A Hovertech Int'L has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2012
- Date Received
- April 30, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lift, Patient, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 880.5500
- Review Panel
- HO
- Submission Type