BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SIGMASTIM DOMESTIC LLC

    Reg #: 3023869663 · FEI: 3023869663 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    SIGMASTIM DOMESTIC LLC
    Registration Number
    3023869663
    FEI Number
    3023869663
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    19799 SW 95th Ave. Suite B
    City
    Tualatin
    State
    OR
    ZIP
    97062
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201309

    Owner / Operator

    Firm Name
    SigmaStim Domestic LLC
    Operator Number
    10085899
    Address
    19799 SW 95th Ave. Suite B
    City
    Tualatin
    State
    OR
    Postal Code
    97062
    Country
    US
    Correspondent
    Adrian Kettering

    Products

    Device Name Product Code
    Block, Bite JXL
    Device, Electroconvulsive Therapy GXC
    Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder QGH

    Proprietary Names

    ECT Cotton Bite Block - Size Large ECT Cotton Bite Block - Size Medium SigmaStim Sigma 200J SigmaStim Sigma 100J

    Establishment Types

    Repack or Relabel Medical Device Manufacture Device in the United States for Export Only Manufacture Medical Device