PKA
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- External Upper Esophageal Sphincter (Ues) Compression Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.5900
- Medical specialty
- Ear, Nose, Throat
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Reza Band, Reflux Band (K173934) | Somna Therapeutics, LLC | 2018-04-13 |
| REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE (DEN130046) | Somna Therapeutics, LLC | 2015-03-06 |
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Every clearance here is in the API, with alerts when new ones post.