K073513 is an FDA 510(k) clearance for the MERITS E700 PORCE LIFT. This device is classified as a Elevator, Wheelchair, Portable (Class II - Special Controls, product code ING).
Submitted by Merits Health Products Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on January 14, 2008, 31 days after receiving the submission on December 14, 2007.
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 | K073513 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2007 |
| Decision Date | January 14, 2008 |
| Days to Decision | 31 days |
| Submission Type | Abbreviated |
| 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). |