BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Topaz

    Reg #: 1531186 · FEI: 3002889431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    INVACARE CORP. DBA INVACARE AMERICA
    Registration Number
    1531186
    FEI Number
    3002889431
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ONE INVACARE WAY
    City
    ELYRIA
    State
    OH
    ZIP
    44035
    Country
    US

    Regulatory Submissions

    510(k) Number
    K060582

    Owner / Operator

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

    Products

    Device Name Product Code
    Wheelchair, Mechanical IOR

    Proprietary Names

    Topaz Invacare 9000 Topaz Wheelchair

    Establishment Types

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