The ActiGraph CentrePoint Insight Watch is a compact, battery-operated wearable activity recording device with physical characteristics similar to those of a small wristwatch. The watch is…
The ActiGraph CentrePoint Insight Watch is a compact, battery-operated wearable activity recording device with physical characteristics similar to those of a small wristwatch. The watch is intended to acquire and store data from an onboard accelerometer while being worn during normal activities and/or during sleep. The data record is timestamped and stored in non-volatile memory for later retrieval. Downloaded data can be post-processed based on the timestamp and magnitude of acceleration along each axis. The housing is constructed of a combination of opaque and clear copolyesters formulated specifically for medical devices (i.e., tested and determined biocompatible), and the core data collection sensor is a 3-axis microelectromechanical system (MEMS) accelerometer. A charging dock connected to a USB power source is used to charge the device battery and communicate with a PC or peripheral.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for ActiGraph | Listed by | ActiGraph L.L.C., United States |
| FDA product code | LEL |
| Device type | Device, Sleep Assessment |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5050 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K231532 |
| Record published | 2024-04-24 |
| Record revised | 2020-03-05 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
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.