Therapeutic devices · 21 CFR 872 Subpart F
Cervical (for Mild Sleep Apnea) Pillow
FDA device type “Pillow, Cervical (For Mild Sleep Apnea)”.
- Companies listing it
- 86 makers
- Brands and models
- 8
- 510(k) clearances
- 60 in five years
- FDA name
- Pillow, Cervical (For Mild Sleep Apnea)
510(k) clearances per year, 1976–2026
Companies that list MYB
8 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Philips Medical Systems International BV | Netherlands | Maker | NightBalance | 16 | 2010 |
| Advanced Brain Monitoring, Inc. | United States | Maker | Night Shift Therapy | 2 | 2014 |
| 2z Medical | United States | Maker | Zzoma · Zzoma Positional Device · Zzoma Positional Sleeper | 1 | 2010 |
| Unitron Group BV | Netherlands | Maker | Lunoa SPT | — | — |
| TPI Custom Solutions | United States | Maker | Zzoma; Zzoma Positional Device; Zzoma Positional Sleeper | — | — |
| Zhejiang E-cozy Electronic Technology Co., Ltd. | China | Maker | Zzoma Positional Device; Zzoma Positional Sleeper | — | — |
| CEVA Logistics Limited | United Kingdom | Foreign exporter | — | — | — |
| CEVA Logistics Netherlands BV | Netherlands | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 5 Jun 2018 | K180608 | Lunoa System | Nightbalance BV |
| 29 May 2014 | K140190 | NIGHT SHIFT | Advanced Brain Monitoring, Inc. |
| 11 May 2010 | K100160 | ZZOMA POSITIONAL SLEEPER MODEL 001 | 2z Medical |
| 30 Apr 2004 | K040161 | SONA PILLOW | Sleep Devices, Inc. |
| 1 Oct 2002 | K023010 | SNIFF POSITION PILLOWS/POPITZ PILLOWS | Aeolus International Corporation |
| 10 Jun 1999 | K990871 | PILLOWPOSITIVE CERVICAL PILLOW | Lifesleep Systems, Inc. |
Official records: FDA product classification for MYB · 21 CFR 872.5570.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026