BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    AMYLIOR, INC.

    Reg #: 9615410 · FEI: 3003767999 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    12
    Establishment Types
    5
    Classifications
    5

    Registration Details

    Registration Name
    AMYLIOR, INC.
    Registration Number
    9615410
    FEI Number
    3003767999
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3190 F.X. Tessier
    City
    Vaudreuil-Dorion Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K994072

    Owner / Operator

    Firm Name
    AMYLIOR, INC.
    Operator Number
    9036363
    Address
    3190 F.X. Tessier
    City
    Vaudreuil-Dorion
    State
    Quebec
    Postal Code
    J7V 5V5
    Country
    CA

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Wheelchair, Powered ITI
    Walker, Mechanical ITJ
    Cushion, Flotation KIC
    Accessories, Wheelchair KNO
    Cushion, Wheelchair IMP

    Proprietary Names

    Interface Tilt PTS 50 CG PTS 50 Alltrack Continent Globe, Stella, CGR CGair Amyseat tilt/recline seating Amyseat Amyseat II tilt/recline seating Amyseat II Amypower Amysystems

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device Foreign Private Label Distributor