System, Communication, Non-powered

Device Code: 5077

Product Code(s): ILP

Device Classification Information

Device Type ID5077
Device NameSystem, Communication, Non-powered
Regulation DescriptionNonpowered Communication System.
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 Number890.3700 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeILP
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5077
DeviceSystem, Communication, Non-powered
Product CodeILP
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionNonpowered Communication System.
CFR Regulation Number890.3700 [🔎]
TPLC Last Update: 2019-04-02 20:59:50

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