# DEN200018: eXciteOSA with remote and eXciteOSA without remote

- Pathway: De Novo (Direct)
- Applicant: Signifier Medical Technologies
- Decided: Feb 5, 2021 after 318 days
- Product code: QNO (Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea)
- Device class: 2
- Regulation: 21 CFR 872.5575
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
eXciteOSA is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue in order to reduce snoring and mild obstructive sleep apnea (AHI<15) for patients that are 18 years or older.

Source page: https://510kreport.com/device/DEN200018
Methodology: https://510kreport.com/methodology