Restraint, Wheelchair, Non-protective

Device Code: 5205

Product Code(s): KID

Device Classification Information

Device Type ID5205
Device NameRestraint, Wheelchair, Non-protective
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 CodeKID
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5205
DeviceRestraint, Wheelchair, Non-protective
Product CodeKID
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionWheelchair Accessory.
CFR Regulation Number890.3910 [🔎]
TPLC Last Update: 2019-04-02 21:02:06

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