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Cutaneous Electrode Stimulator For Urinary Incontinence

FDA product code QAJ · 4 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.5330
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-02-11 – 2026-01-23

A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.

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