SNORING CONTROL DEVICE

• K Number: K963591
• Device Name: SNORING CONTROL DEVICE
• Manufacturer: KENNETH HILSEN
• Date Cleared: 1998-01-09 ( 487 days)
• Product Code: LRK
• Regulation Number: 872.5570
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

The Anti-Snoring Device is intended to alleviate or correct snoring.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for a "Snoring Control Device" and an "Indications For Use" statement. This document does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications as requested. Therefore, I cannot generate the specific information you are looking for.

Regulation Number and Section

§ 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.”