Stocking, Elastic

Device Code: 5070

Product Code(s): ILG

Device Classification Information

Device Type ID5070
Device NameStocking, Elastic
Regulation DescriptionLimb Orthosis.
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 Number890.3475 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeILG
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5070
DeviceStocking, Elastic
Product CodeILG
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionLimb Orthosis.
CFR Regulation Number890.3475 [🔎]
Device Problems
Device Markings / Labelling Problem
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 20:59:44

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