SIGMASTIM DOMESTIC LLC

FDA Device Registration & Listing · Tualatin, OR, US · Registration 3023869663

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3023869663
FEI Number
3023869663
Entity Name
SIGMASTIM DOMESTIC LLC
City/State/Country
Tualatin, OR, US
Establishment Address
19799 SW 95th Ave. Suite B, Tualatin, OR 97062, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SigmaStim Domestic LLC (Owner Number: 10085899)
Owner / Operator Contact Address
19799 SW 95th Ave. Suite B, Tualatin, OR 97062, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K192834
PMA Number
N/A

All Registered Proprietary Names

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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JXL Block, Bite Neurology Class 2 882.5070 2023-12-07
GXC Device, Electroconvulsive Therapy Neurology Class 3 882.5940 2022-09-01
QGH Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder Neurology Class 2 882.5940 2022-09-01

Official Correspondent

Adrian Kettering

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SigmaStim Domestic LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023869663. Last updated year: 2026. Please use registration number 3023869663 when referencing this establishment in official correspondence.
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