K061514 is an FDA 510(k) clearance for the BRUNO VERTICAL PLATFORM LIFT, MODEL VPL-3100. This device is classified as a Elevator, Wheelchair, Portable (Class II - Special Controls, product code ING).
Submitted by Bruno Independent Living Aids, Inc. (Oconomowoc, US). The FDA issued a Cleared decision on July 13, 2006, 42 days after receiving the submission on June 1, 2006.
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 | K061514 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2006 |
| Decision Date | July 13, 2006 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| 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). |