Night Shift
Night Shift is a neck-worn device for positional obstructive sleep apnea that detects when the wearer lies on their back. It delivers vibration that increases in intensity until the wearer…
Night Shift is a neck-worn device for positional obstructive sleep apnea that detects when the wearer lies on their back. It delivers vibration that increases in intensity until the wearer changes to a non-supine position.
The feedback can start after a programmed delay to allow time to fall asleep. The device also records position, movement and sound, including time spent supine, snoring measures and the duration and intensity of feedback.
Listed Item
Night Shift LE Device Starter Kit French+English
Recorded Feedback
Recorded data can be transferred by USB to reporting software for viewing use and positional-feedback patterns. The system includes a web portal and a desktop-software alternative, combining the wearable feedback unit with tools for reviewing its overnight record.
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 | Advanced Brain Monitoring, Inc., United States |
|---|---|
| FDA product code | MYB |
| Device type | Pillow, Cervical (For Mild Sleep Apnea) |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5570 |
| Establishment | Manufacturer |
| 510(k) | K140190 |
| Record published | 2024-03-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -25 to 70 °C; Storage environment humidity 15 to 93 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 15 to 93 % RH; Handling environment temperature 5 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NS27-1005.LE(SWISS) | In distribution | |
| NS27-1010.LE(ENSO) | In distribution | |
| NS27-1005.LE(GER) | In distribution | |
| NS27-1010.LE | In distribution | |
| NS27-1005.LE(FIN) | In distribution | |
| NS27-1005.LE(NOR) | In distribution | |
| NS27-1005.LE(ENSO) | In distribution | |
| NS27-1005.LE | In distribution | |
| NS27-1005.LE(ITA) | In distribution | |
| NS27-1005.LE(DUT) | In distribution | |
| NS27-1005.LE(DAN) | In distribution | |
| NS27-1010.LE | In distribution | |
| NS27-1005, NS27-1006 | In distribution | |
| NS27-1005.LE(TCHI) | In distribution | |
| NS27-1005.LE(POR) | In distribution | |
| NS27-1005.LE(FRE) | In distribution | |
| NS27-1010.LE(FRE) | In distribution | |
| NS27-1005.LE(DUTFRE) | In distribution | |
| NS27-1005.LE(SWE) | In distribution | |
| NS27-1005.LE(SPA) | In distribution | |
| NS27-1005.R | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NightBalance | Respironics Inc. | 6 |
| Lunoa | NightBalance Holding B.V. | 2 |
| Zzoma | 2Z Medical | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140190 | 2014-05-29 |
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.