| 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 Code | PKA |
|---|
| 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
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
