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

FDA product code QHH · 5 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.5340
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2020-12-29 – 2025-10-16

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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