Product code QXM

Device name
Implanted Tibial Electrical Urinary Continence Device
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation number
876.5305
Review panel
GU
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.
Source
FDA openFDA device classification dataset