BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ActiGraph L.L.C.

    Reg #: 3004091281 · FEI: 3006254866 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    6
    Establishment Types
    3
    Classifications
    8

    Registration Details

    Registration Name
    ActiGraph L.L.C.
    Registration Number
    3004091281
    FEI Number
    3006254866
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    70 North Baylen Street, Suite 400
    City
    Pensacola
    State
    FL
    ZIP
    32502
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233418

    Owner / Operator

    Firm Name
    ActiGraph, LLC
    Operator Number
    10023162
    Address
    70 North Baylen Street, Suites 300-400
    City
    Pensacola
    State
    FL
    Postal Code
    32502
    Country
    US
    Correspondent
    Brian A Bell

    Products

    Device Name Product Code
    Oximeter DQA
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    System, Network And Communication, Physiological Monitors MSX
    Monitor, Breathing Frequency BZQ
    Medical Device Data System OUG
    Device, Sleep Assessment LEL
    Exerciser, Measuring ISD

    Proprietary Names

    Everion+ (G2) System CentrePoint Data Hub ActiGraph LEAP CPW01 actiGO; ActiGraph GT9X Link; ActiSleep; ActiSleep+; ActiTrainer; GT3X; GT3X+; wActiSleep+; wActiSleep-BT; wGT3X+; wGT3X Everion+ System

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device