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Implanted Tibial Electrical Urinary Continence Device

Implanted Tibial Electrical Urinary Continence Device is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Implanted Tibial Electrical Urinary Continence Device
Gastroenterology, Urology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QXM

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Class 2

21 CFR 876.5305

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Gastroenterology, Urology

Device Characteristics

No

Yes

No

Not Eligible

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.