(161 days)
The Moses™ appliance is intended for use on adult patients 18 years of age and older as an aid for the reduction and/or alleviation of snoring and mild to moderate obstructive sleep apnea.
Not Found
I am sorry, but the provided text is a letter from the FDA regarding the 510(k) premarket notification for "The Moses™ Appliance". It is a regulatory document and does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on:
- Confirming that the device is substantially equivalent to legally marketed predicate devices.
- Outlining the general controls and regulations the manufacturer must comply with.
- Stating the intended use/indications for the device.
Therefore, I cannot provide the requested information based on the given input.
§ 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.”