BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ALKEN, INC. D/B/A POLHEMUS

    Reg #: 1000246715 · FEI: 1000246715 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    ALKEN, INC. D/B/A POLHEMUS
    Registration Number
    1000246715
    FEI Number
    1000246715
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    40 Hercules Drive
    City
    Colchester
    State
    VT
    ZIP
    05446
    Country
    US

    Regulatory Submissions

    510(k) Number
    K081787

    Owner / Operator

    Firm Name
    Alken, Inc. d/b/a Polhemus
    Operator Number
    10028587
    Address
    40 Hercules Drive
    City
    Colchester
    State
    VT
    Postal Code
    05446
    Country
    US
    Correspondent
    Skip G Rodgers

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK
    Orthosis, Cranial MVA
    Orthosis, Cranial, Laser Scan OAN

    Proprietary Names

    FastSCAN II

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198