510(k) K173934
K173934 is an FDA 510(k) premarket notification submitted by Somna Therapeutics, LLC for the device "Reza Band, Reflux Band". The FDA issued a decision of Substantially Equivalent on Apr 13, 2018. The device falls under product code PKA (External Upper Esophageal Sphincter (Ues) Compression Device), a Class II device regulated under 21 CFR 874.5900. Somna Therapeutics, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 13, 2018
- Date Received
- Dec 26, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- External Upper Esophageal Sphincter (Ues) Compression Device
- Device Class
- Class II
- Regulation Number
- 874.5900
- Review Panel
- EN
- Submission Type
- 510(k)
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.