(22 days)
To reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea (OSA).
The TAP T Anti -- snoring device is comprised of -- - 트 Lower tray fitted over the lower teeth. - . Upper tray fitted over the upper teeth. - 트 Impression material - . Hook mechanism to attach to lower tray to upper tray
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any specific criteria. The document is a 510(k) premarket notification summary for the TAP T device, outlining its description, intended use, and substantial equivalence to predicate devices, but it does not contain details of any performance studies or acceptance criteria.
Therefore, I cannot provide the requested information.
§ 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.”