Elevator, Wheelchair, Portable

Device Code: 5112

Product Code(s): ING

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 Classification Information

Device Type ID5112
Device NameElevator, Wheelchair, Portable
Regulation DescriptionWheelchair Elevator.
Regulation Medical SpecialtyPhysical Medicine
Review PanelPhysical Medicine
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Physical Medicine And Rehabilitation Devices Branch (PMDB)
Submission Type510(k)
CFR Regulation Number890.3930 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeING
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID5112
DeviceElevator, Wheelchair, Portable
Product CodeING
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionWheelchair Elevator.
CFR Regulation Number890.3930 [🔎]
Device Problems
Use Of Device Problem
7
Labelling, Instructions For Use Or Training Problem
2
Unintended System Motion
1
Total Device Problems 10
TPLC Last Update: 2019-04-02 21:00:25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.