FDA.reportPublic FDA data

ActiGraph L.L.C.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30040912813006254866ActiGraph L.L.C.1N2026-01-0170 North Baylen Street Suite 400 Pensacola FL US 32502

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
726331962602874K233418Biofourmis Everion+ (G2)MSX2024-05-09
726331450012790K231532ActiGraph LEAP activity monitor (ActiGraph LEAP)LEL2023-06-23
726331475714218K213863Everion+ SystemMSX2023-02-23
726331337126008K181077ActiGraph CentrePoint Insight WatchLEL2018-05-24
726331537511907K080545ACTITRAINERISD2008-07-24
726331166045888K040554ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256GWQ2004-07-16
726331213184838

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MSX22024-05-09
LEL22023-06-23
ISD22008-07-24
GWQ12004-07-16

GUDID#

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.

ACTIGRAPH L.L.C.

2018-10-16