ActiGraph LEAP activity monitor (ActiGraph LEAP)
Actigraph, LLC
ActiGraph L.L.C.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004091281 | 3006254866 | ActiGraph L.L.C. | 1 | N | 2026-01-01 | 70 North Baylen Street Suite 400 Pensacola FL US 32502 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 72633 | 1962602874 | K233418 | Biofourmis Everion+ (G2) | MSX | 2024-05-09 |
| 72633 | 1450012790 | K231532 | ActiGraph LEAP activity monitor (ActiGraph LEAP) | LEL | 2023-06-23 |
| 72633 | 1475714218 | K213863 | Everion+ System | MSX | 2023-02-23 |
| 72633 | 1337126008 | K181077 | ActiGraph CentrePoint Insight Watch | LEL | 2018-05-24 |
| 72633 | 1537511907 | K080545 | ACTITRAINER | ISD | 2008-07-24 |
| 72633 | 1166045888 | K040554 | ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256 | GWQ | 2004-07-16 |
| 72633 | 1213184838 |
Product Codes Associated With Registrations#
PMN#
GUDID#
ActiGraph - The ActiGraph LEAP™ is a small, worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. The ActiGraph LEAP™ can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
2024-04-24
ActiGraph - 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.
2018-10-16
ActiGraph - The GT9X is a body worn device that measures and records physical movement associated with daily activity and sleep. The GT9X is intended for use in applications where quantifiable measurement and storage of physical movement is desired.
2017-12-28
Actigraph - The wGT3X-BT is a body worn device that measures and records physical movement associated with daily activity and sleep. The wGT3X-BT is intended for use in applications where quantifiable measurement and storage of physical movement is desired.
2017-12-28
ActiGraph - The CentrePoint Data Hub is a home-based communication gateway that securely transmits data captured by ActiGraph activity monitors.
2017-12-28