Wheelchair, Stair Climbing

Device Code: 5094

Product Code(s): IMK

Definition: PMA To Be Filed By 7/12/00 (65 FR 19834 (4/13/00))

Device Classification Information

Device Type ID5094
Device NameWheelchair, Stair Climbing
Regulation DescriptionStair-climbing Wheelchair.
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 Number890.3890 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeIMK
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5094
DeviceWheelchair, Stair Climbing
Product CodeIMK
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionStair-climbing Wheelchair.
CFR Regulation Number890.3890 [🔎]
TPLC Last Update: 2019-04-02 21:00:09

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