MYB · Pillow, Cervical (For Mild Sleep Apnea)
Dental · 21 CFR 872.5570 · Class 2
Overview
| Product Code | MYB |
|---|---|
| Device Name | Pillow, Cervical (For Mild Sleep Apnea) |
| Regulation | 21 CFR 872.5570 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
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.”
Special Controls
*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.”
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K180608 | Lunoa System | Nightbalance BV | Jun 5, 2018 | SESE |
| K140190 | NIGHT SHIFT | Advanced Brain Monitoring, Inc. | May 29, 2014 | SESE |
| K100160 | ZZOMA POSITIONAL SLEEPER MODEL 001 | Sleep Specialists, LLC | May 11, 2010 | SESE |
| K040161 | SONA PILLOW | Sleep Devices, Inc. | Apr 30, 2004 | SESE |
| K023010 | SNIFF POSITION PILLOWS/POPITZ PILLOWS | Aeolus International Corporation | Oct 1, 2002 | SESE |
| K990871 | PILLOWPOSITIVE CERVICAL PILLOW | Lifesleep Systems, Inc. | Jun 10, 1999 | SESE |
Top Applicants
- Advanced Brain Monitoring, Inc. — 1 clearance
- Aeolus International Corporation — 1 clearance
- Lifesleep Systems, Inc. — 1 clearance
- Nightbalance BV — 1 clearance
- Sleep Devices, Inc. — 1 clearance
