Cuff, Pusher, Wheelchair

Device Code: 5109

Product Code(s): INC

Device Classification Information

Device Type ID5109
Device NameCuff, Pusher, Wheelchair
Regulation DescriptionWheelchair Accessory.
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 Number890.3910 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeINC
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5109
DeviceCuff, Pusher, Wheelchair
Product CodeINC
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionWheelchair Accessory.
CFR Regulation Number890.3910 [🔎]
TPLC Last Update: 2019-04-02 21:00:22

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