Product code PKA

Device name

External Upper Esophageal Sphincter (Ues) Compression Device

Medical specialty

Ear, Nose, Throat

Device class

2

Regulation number

874.5900

Review panel

EN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

The external UES compression device is intended to reduce the symptoms of laryngopharyngeal reflux (LPR) disease by reducing the regurgitation of stomach contents from passing through the upper esophageal sphincter.

Source

FDA openFDA device classification dataset