Stimulator, Peripheral Nerve, Non-implanted, For Pelvic Floor Dysfunction

Device Code: 2012

Product Code(s): NAM

Device Classification Information

Device Type ID2012
Device NameStimulator, Peripheral Nerve, Non-implanted, For Pelvic Floor Dysfunction
Regulation DescriptionNonimplanted, Peripheral Electrical Continence Device.
Regulation Medical SpecialtyGastroenterology/Urology
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Urology And Lithotripsy Devices Branch (ULDB)
Submission Type510(k)
CFR Regulation Number876.5310 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNAM
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2012
DeviceStimulator, Peripheral Nerve, Non-implanted, For Pelvic Floor Dysfunction
Product CodeNAM
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionNonimplanted, Peripheral Electrical Continence Device.
CFR Regulation Number876.5310 [🔎]
Device Problems
Adverse Event Without Identified Device Or Use Problem
 75
Device Operates Differently Than Expected
 4
Failure To Deliver Energy
2
Material Deformation
 1
Positioning Problem
 1
Total Device Problems 83
TPLC Last Update: 2019-04-02 20:04:11
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