Adaptor, Grooming

Device Code: 5081

Product Code(s): ILW

Device Classification Information

Device Type ID5081
Device NameAdaptor, Grooming
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 CodeILW
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5081
DeviceAdaptor, Grooming
Product CodeILW
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDaily Activity Assist Device.
CFR Regulation Number890.5050 [🔎]
TPLC Last Update: 2019-04-02 20:59:55

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