Cutaneous Electrode Stimulator For Urinary Incontinence
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation number
876.5330
Review panel
GU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.