# K173934: Reza Band, Reflux Band

- Pathway: 510(k) (Traditional)
- Applicant: Somna Therapeutics, LLC
- Decided: Apr 13, 2018 after 108 days
- Product code: PKA (External Upper Esophageal Sphincter (Ues) Compression Device)
- Device class: 2
- Regulation: 21 CFR 874.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN130046 (2015). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130046: Reza Band (TM) Upper Esophageal (Ues) Sphincter Assist Device, Somna Therapeutics, LLC (2015) Summary page 4.

## Indications for use
The Reza Band and the Reflux Band are for people 18 years and older to reduce the symptoms of laryngopharyngeal reflux (LPR) disease by reducing the regurgitation of stomach contents from passing through the upper esophageal sphincter. The devices are worn by the user while sleeping.

Source page: https://510kreport.com/device/K173934
Methodology: https://510kreport.com/methodology