Permanently Mounted Wheelchair Platform Lift

Device Code: 5239

Product Code(s): PCE

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 Classification Information

Device Type ID5239
Device NamePermanently Mounted Wheelchair Platform Lift
Physical StateA Permanently Mounted Wheelchair Platform Lift Is A Motorized Vertical Or Inclined Platform Lift Device Permanently Installed In One Location.
Technical MethodA Permanently Mounted Guided Platform To Move A Person With Impaired Mobility, With Or Without A Wheelchair, From One Level To Another.
Target AreaN/a
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) Exempt
CFR Regulation Number890.3930 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodePCE
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5239
DevicePermanently Mounted Wheelchair Platform Lift
Product CodePCE
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionWheelchair Elevator.
CFR Regulation Number890.3930 [🔎]
TPLC Last Update: 2019-04-02 21:02:40

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