QXM — Implanted Tibial Electrical Urinary Continence Device Class II

FDA Device Classification

Classification Details

Product Code
QXM
Device Class
Class II
Regulation Number
876.5305
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
Yes

Definition

An implanted tibial electrical urinary continence device is an implanted prescription device that receives power from a non-implanted external power source to provide electrical stimulation of the tibial nerve in proximity to the ankle. The device is intended for the treatment of overactive bladder related symptoms of urge urinary incontinence, urinary urgency, urinary frequency and nocturia.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252391bluewind medicalRevi SystemDecember 12, 2025
K240037bluewind medicalRevi™ SystemMay 2, 2024
DEN220073bluewind medicalRevi SystemAugust 16, 2023