BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Helio

    Reg #: 3011134213 · FEI: 3011134213 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MOTION COMPOSITES
    Registration Number
    3011134213
    FEI Number
    3011134213
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    160 Armand Majeau Sud
    City
    St-Roch-de-lAchigan Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K120628

    Owner / Operator

    Firm Name
    Motion Composites
    Operator Number
    10047250
    Address
    160 rue Armand-Majeau Sud
    City
    St-Roch-de-l'Achigan
    State
    Quebec
    Postal Code
    J0K3H0
    Country
    CA
    Correspondent
    Eric Simoneau

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Wheelchair, Mechanical IOR

    Proprietary Names

    Helio Veloce

    Establishment Types

    Manufacture Medical Device