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.
| Device Type ID | 1638 |
| Device Name | External Upper Esophageal Sphincter (ues) Compression Device |
| 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 Description | External Upper Esophageal Sphincter Compression Device. |
| Regulation Medical Specialty | Ear Nose & Throat |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 874.5900 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PKA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1638 |
| Device | External Upper Esophageal Sphincter (ues) Compression Device |
| Product Code | PKA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | External Upper Esophageal Sphincter Compression Device. |
| CFR Regulation Number | 874.5900 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SOMNA THERAPEUTICS, L.L.C. | ||
GRANTED | 1 | |