Neurovirtual
The Maxxi Position Sensor is intended for use with the polysomnograph system to acquire the body position of adult patients during sleep studies
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Fenda Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
Record
| Listed by | Neurovirtual USA, Inc., United States |
|---|---|
| FDA product code | LEL |
| Device type | Device, Sleep Assessment |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5050 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K191492 |
| Record published | 2020-08-06 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Storage environment temperature -4 to 140 °F; Storage environment temperature -20 to 60 °C; Storage environment humidity 5 to 95 % RH; Handling environment temperature 40 to 104 °F; Handling environment temperature 5 to 40 °C; Handling environment humidity 5 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Maxxi Position Sensor | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Braebon Ultima Body Position Sensor | Braebon Medical Corp. | 5 |
| EmbraceMini | Empatica SRL | 2 |
| Braebon Ultima Body Position Sensor for Alice 5 | Braebon Medical Corp. | 2 |
| MotionWatch | Camntech | 2 |
| PRO-Diary | Camntech | 2 |
| ActiGraph | ActiGraph L.L.C. | 2 |
| Actiwave | Camntech | 1 |
| EasyNet | Cadwell Industries, Inc. | 1 |
| Braebon Ultima Body Position Sensor with 2.5 mm phone connector | Braebon Medical Corp. | 1 |
| Oxevision Sleep system | Oxehealth Ltd | 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.