BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    E-Fix E35/E36

    Reg #: 3004730072 · FEI: 3004730072 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ALBER GMBH
    Registration Number
    3004730072
    FEI Number
    3004730072
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VOR DEM Weiben STEIN 14
    City
    ALBSTADT Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K161241

    Owner / Operator

    Firm Name
    Invacare Corporation
    Operator Number
    1525712
    Address
    One Invacare Way
    City
    Elyria
    State
    OH
    Postal Code
    44035
    Country
    US

    US Agent

    Business Name
    Invacare Corporation DBA Invacare America
    Contact Name
    Michael Simmons
    Address
    One Invacare Way
    City
    Elyria
    State
    OH
    ZIP
    44035
    Country
    US
    Email
    [email protected]
    Phone
    440 9351269

    Products

    Device Name Product Code
    Wheelchair, Powered ITI

    Proprietary Names

    E-Fix E35/E36 E-Fix Eco

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility