K113065 is an FDA 510(k) clearance for the RL, UL, SL, EL, AND EPL VERTICAL PLATFORM LIFTS. This device is classified as a Elevator, Wheelchair, Portable (Class II - Special Controls, product code ING).
Submitted by Bella Elevator, LLC (Peoria, US). The FDA issued a Cleared decision on February 22, 2012, 131 days after receiving the submission on October 14, 2011.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3930. A Motorized Lift Device That Is Not Permanently Mounted In One Location And That Is Intended For Medical Purposes To Provide A Means To Move A Person With Impaired Mobility, With Or Without A Wheelchair, From One Level To Another (e.g., Portable Platform Lifts, Attendant-operated Stair Climbing Devices For Wheelchairs)..
| 510(k) Number | K113065 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 2011 |
| Decision Date | February 22, 2012 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ING — Elevator, Wheelchair, Portable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3930 |
| Definition | A Motorized Lift Device That Is Not Permanently Mounted In One Location And That Is Intended For Medical Purposes To Provide A Means To Move A Person With Impaired Mobility, With Or Without A Wheelchair, From One Level To Another (e.g., Portable Platform Lifts, Attendant-operated Stair Climbing Devices For Wheelchairs). |