K091881 is an FDA 510(k) clearance for the RPL/CPL VERTICAL PLATFORM LIFTS. This device is classified as a Elevator, Wheelchair, Portable (Class II - Special Controls, product code ING).
Submitted by Harmar Summit, LLC (Sarasota, US). The FDA issued a Cleared decision on July 1, 2009, 7 days after receiving the submission on June 24, 2009.
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 | K091881 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2009 |
| Decision Date | July 01, 2009 |
| Days to Decision | 7 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). |