Data / Medical devices / United States / ActiGraph L.L.C.

ActiGraph L.L.C.: FDA-registered device maker in Pensacola, FL, United States, 5 510(k) clearances

Name: ActiGraph L.L.C. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

ActiGraph L.L.C. is registered with the FDA (registration 3004091281) in Pensacola, FL, United States. It lists 8 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 9, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004091281
FEI number: 3006254866
Address: 70 North Baylen Street Suite 400, Pensacola, FL, United States, 32502
Owner or operator: ActiGraph, LLC (10023162)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: February 16, 2010
Registered through: 2026
Brand names listed: ActiGraph LEAP, CPW01, CentrePoint Data Hub, Everion+ (G2) System, Everion+ System, actiGO; ActiGraph GT9X Link; ActiSleep; ActiSleep+; ActiTrainer; GT3X; GT3X+; wActiSleep+; wActiSleep-BT; wGT3X+; wGT3X

Devices it lists

Device	Product code	Class	Role	Source
Device, Sleep Assessment	LEL	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Exerciser, Measuring	ISD	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Medical Device Data System	OUG	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Oximeter	DQA	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
System, Network And Communication, Physiological Monitors	MSX	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Transmitters And Receivers, Physiological Signal, Radiofrequency	DRG	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 9, 2024	K233418	Biofourmis Everion+ (G2)	MSX	Substantially Equivalent	Biofourmis Singapore Pte., Ltd.	accessdata.fda.gov
June 23, 2023	K231532	ActiGraph LEAP activity monitor (ActiGraph LEAP)	LEL	Substantially Equivalent	Actigraph, LLC	accessdata.fda.gov
February 23, 2023	K213863	Everion+ System	MSX	Substantially Equivalent	Biofourmis Singapore Pte., Ltd.	accessdata.fda.gov
May 24, 2018	K181077	ActiGraph CentrePoint Insight Watch	LEL	Substantially Equivalent	Actigraph	accessdata.fda.gov
July 24, 2008	K080545	ACTITRAINER	ISD	Substantially Equivalent	Actigraph, LLC	accessdata.fda.gov

Compare with other makers

Updated May 9, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.