Zzoma
The Zzoma Positional Device is an FDA-cleared positional medical device for the treatment of mild to moderate positional Obstructive Sleep Apnea (OSA).
1manufacturer
1catalogue number
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang E-Cozy Electronic Technology Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
Record
| Listed by | 2Z Medical |
|---|---|
| FDA product code | MYB |
| Device type | Pillow, Cervical (For Mild Sleep Apnea) |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5570 |
| 510(k) | K100160 |
| Record published | 2016-11-11 |
| Record revised | 2023-09-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Night Shift | Advanced Brain Monitoring, Inc. | 21 |
| NightBalance | Respironics Inc. | 6 |
| Lunoa | NightBalance Holding B.V. | 2 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.