SNIFF POSITION PILLOWS/POPITZ PILLOWS

• K Number: K023010
• Device Name: SNIFF POSITION PILLOWS/POPITZ PILLOWS
• Manufacturer: AEOLUS INTERNATIONAL CORPORATION
• Date Cleared: 2002-10-01 ( 22 days)
• Product Code: MYB
• Regulation Number: 872.5570
• Type: Abbreviated
• Panel: EN
• Reference & Predicate Devices: N/A

Intended Use

The Sniff Position Pillows are indicated for the following uses:

• 1.) May improve the quality of sleep
• 2.) May improve the symptoms of mild obstructive sleep apnea
• 3.) May improve snoring

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA regarding the classification of "Sniff Position Pillows/Popitz Pillows." It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information. The letter primarily addresses the regulatory classification of the device.

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.”