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U.S. Department of Health and Human Services

Product Classification

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Device external upper esophageal sphincter (ues) compression device
Regulation Description External upper esophageal sphincter compression device.
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.
Physical State The external UES compression device consists of an externally worn band. The band typically consists of a cushion, a comfort band, a frame, comfort dial and clasp.
Technical Method The external UES compression device is worn by the patient and is designed to provide a set pressure on the cricoid cartilage, which increases the luminal pressure within the upper esophageal sphincter (UES).
Target Area An upper esophageal sphincter (UES) compression device, which applies external pressure on the cricoid cartilage right below the Adam's apple.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodePKA
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 874.5900
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible