Attachment, Narrowing, Wheelchair

Device Code: 5100

Product Code(s): IMQ

Device Classification Information

Device Type ID5100
Device NameAttachment, Narrowing, 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 CodeIMQ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5100
DeviceAttachment, Narrowing, Wheelchair
Product CodeIMQ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionWheelchair Component.
CFR Regulation Number890.3920 [🔎]
TPLC Last Update: 2019-04-02 21:00:14

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