510(k) DEN180057

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

June 7, 2019

Date Received

October 25, 2018

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

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

Device Class

Class II

Regulation Number

876.5340

Review Panel

GU

Submission Type

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.