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

QHH · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5340

Classification

FDA Product Code: QHH
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.5340
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 6
Registered establishments: 5

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown