Actiwave
Ambulatory Accelerometry recorder - triaxial
1manufacturer
1catalogue number
1510(k) clearance
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 | Camntech, United Kingdom |
|---|---|
| FDA product code | LEL |
| Device type | Device, Sleep Assessment |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5050 |
| Establishment | Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2024-11-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2023-04-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Motion | Withdrawn |
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 |
| Neurovirtual | Neurovirtual USA, Inc. | 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 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K132764 | 2014-01-21 |
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.