Adaptor, Dressing

Device Code: 5068

Product Code(s): ILD

Device Classification Information

Device Type ID5068
Device NameAdaptor, Dressing
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 CodeILD
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5068
DeviceAdaptor, Dressing
Product CodeILD
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDaily Activity Assist Device.
CFR Regulation Number890.5050 [🔎]
TPLC Last Update: 2019-04-02 20:59:41

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