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6 FDA 510(k) clearances · Product code

FDA profile

Official device name

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

Device class

Class II (moderate risk)

Regulation

21 CFR 876.5340

Medical specialty

Gastroenterology, Urology

FDA 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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