Product code QQG

Device name

Oropharyngeal Electrical Stimulator

Medical specialty

Ear, Nose, Throat

Device class

2

Regulation number

874.5950

Review panel

EN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset