Data / Medical devices / Pillow, Cervical (For Mild Sleep Apnea)
Pillow, Cervical (For Mild Sleep Apnea) (MYB): 6 FDA-registered makers in 3 countries
6 establishments in 3 countries are registered with the FDA to make Pillow, Cervical (For Mild Sleep Apnea) (product code MYB, Class 2, 21 CFR 872.5570). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on June 5, 2018, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MYB
- Device class
- 2
- Regulation
- 872.5570
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Netherlands | 1 |
| China | 1 |
Makers of Pillow, Cervical (For Mild Sleep Apnea)
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Advanced Brain Monitoring, Inc. | Carlsbad, CA, United States | Manufacturer | 1 | May 29, 2014 | 0 | 0 | 0 | api.fda.gov |
| Respironics Inc. | Murrysville, PA, United States | Complaint file establishment, Specification developer | 1 | June 5, 2018 | 0 | 0 | 0 | api.fda.gov |
| Sleep Specialists, LLC | Bala Cynwyd, PA, United States | Specification developer | 1 | May 11, 2010 | 0 | 0 | 0 | api.fda.gov |
| TPI Custom Solutions | Ham Lake, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unitron Group BV | IJzendijke Zeeland, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang E-Cozy Electronic Technology Co., Ltd. | Wenzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 5, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.