(39 days)
The MPowRx™ Snoring Solution (Also known as Good Morning Snore Solution®) is intended as an aid in the reduction of snoring for adults at least 18 years old.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the MPowRx Snoring Solution. While it confirms the device's substantial equivalence to a predicate device and states its intended use, it does not contain any information regarding specific acceptance criteria, device performance metrics, study design, or methodology used to prove the device meets these criteria.
Therefore, I cannot answer your questions based on the provided input. The document focuses on regulatory clearance, not on a detailed clinical or performance study report.
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”