Definition: Intended For Medical Purposes To Provide A Guided Platform To Move A Person With Impaired Mobility, With Or Without A Wheelchair, From One Level To Another.
Device Type ID | 5239 |
Device Name | Permanently Mounted Wheelchair Platform Lift |
Physical State | A Permanently Mounted Wheelchair Platform Lift Is A Motorized Vertical Or Inclined Platform Lift Device Permanently Installed In One Location. |
Technical Method | A Permanently Mounted Guided Platform To Move A Person With Impaired Mobility, With Or Without A Wheelchair, From One Level To Another. |
Target Area | N/a |
Regulation Description | Wheelchair Elevator. |
Regulation Medical Specialty | Physical Medicine |
Review Panel | Physical Medicine |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 890.3930 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | PCE |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5239 |
Device | Permanently Mounted Wheelchair Platform Lift |
Product Code | PCE |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Wheelchair Elevator. |
CFR Regulation Number | 890.3930 [🔎] |