Oropharyngeal Electrical Stimulator

QQG · Class II — Moderate Risk (510(k) clearance required) · Ear, Nose, Throat · 21 CFR 874.5950

Classification

FDA Product Code: QQG
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 874.5950
Review panel: EN
Medical specialty: Ear, Nose, Throat
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

An oropharyngeal electrical stimulator is a device that stimulates afferent nerve fibers of oropharyngeal mucosa. The device is intended to treat swallowing dysfunction. The device may incorporate a feeding tube.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 3

Source

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