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 | ||
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Manufacturer | Decision | |
SOMNA THERAPEUTICS, L.L.C. | ||
GRANTED | 1 |