Product code KPI

Device name

Stimulator, Electrical, Non-Implantable, For Incontinence

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.5320

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Source

FDA openFDA device classification dataset