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 Plat
Device Type ID | 5112 |
Device Name | Elevator, Wheelchair, Portable |
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) |
CFR Regulation Number | 890.3930 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | ING |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
Device Type ID | 5112 |
Device | Elevator, Wheelchair, Portable |
Product Code | ING |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Wheelchair Elevator. |
CFR Regulation Number | 890.3930 [🔎] |
Device Problems | |
---|---|
Use Of Device Problem | 7 |
Labelling, Instructions For Use Or Training Problem | 2 |
Unintended System Motion | 1 |
Total Device Problems | 10 |