Footrest, Wheelchair

Device Code: 5096

Product Code(s): IMM

Device Classification Information

Device Type ID5096
Device NameFootrest, Wheelchair
Regulation DescriptionWheelchair Component.
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 Number890.3920 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeIMM
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5096
DeviceFootrest, Wheelchair
Product CodeIMM
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionWheelchair Component.
CFR Regulation Number890.3920 [🔎]
Device Problems
Break
4
Crack
2
Product Quality Problem
1
Device Inoperable
1
Bent
1
Total Device Problems 9
TPLC Last Update: 2019-04-02 21:00:11

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