Plinth

Device Code: 5120

Product Code(s): INT

Device Classification Information

Device Type ID5120
Device NamePlinth
Regulation DescriptionPlinth.
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 Number890.3520 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeINT
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5120
DevicePlinth
Product CodeINT
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPlinth.
CFR Regulation Number890.3520 [🔎]
TPLC Last Update: 2019-04-02 21:00:35

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