FDA product code QHH

Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)

Gastroenterology, Urology·Class 2·21 CFR 876.5340
US regulatory classifications
US Product Code (FDA)
QHH
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 876.5340
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Medical specialty
Gastroenterology, Urology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A non-implanted nerve stimulator for functional abdominal pain relief is a device that stimulates nerves remotely from the source of pain with the intent to relieve functional abdominal pain. This generic type of device does not include devices designed to relieve pelvic pain.

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About this record

Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs) 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.

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.