Lunoa
Lunoa Sleep Position Trainer, US
1manufacturer
2catalogue numbers in this listing
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 | NightBalance Holding B.V. |
|---|---|
| FDA product code | MYB |
| Device type | Pillow, Cervical (For Mild Sleep Apnea) |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5570 |
| 510(k) | K180608 |
| Record published | 2018-08-20 |
| Record revised | 2023-09-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment temperature -25 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| L1CHST01 | In distribution | |
| L1US01US | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Night Shift | Advanced Brain Monitoring, Inc. | 21 |
| NightBalance | Respironics Inc. | 6 |
| Zzoma | 2Z Medical | 1 |
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.