Utensil, Eating

Device Code: 5067

Product Code(s): ILC

Device Classification Information

Device Type ID5067
Device NameUtensil, Eating
Regulation DescriptionDaily Activity Assist Device.
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 Number890.5050 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeILC
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5067
DeviceUtensil, Eating
Product CodeILC
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDaily Activity Assist Device.
CFR Regulation Number890.5050 [🔎]
TPLC Last Update: 2019-04-02 20:59:40

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