Data / Medical devices / United States / Sigmastim Domestic LLC
Sigmastim Domestic LLC: FDA-registered device maker in Tualatin, OR, United States, 2 510(k) clearances
Sigmastim Domestic LLC is registered with the FDA (registration 3023869663) in Tualatin, OR, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 4, 2021. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3023869663
- Address
- 19799 SW 95th Ave. Suite B, Tualatin, OR, United States, 97062
- Owner or operator
- SigmaStim Domestic LLC (10085899)
- Roles
- Manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- September 1, 2022
- Registered through
- 2026
- Brand names listed
- ECT Cotton Bite Block - Size Large, ECT Cotton Bite Block - Size Medium, SigmaStim Sigma 100J, SigmaStim Sigma 200J
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Block, Bite | JXL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Device, Electroconvulsive Therapy | GXC | 3 | Manufacturer for export | accessdata.fda.gov |
| Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder | QGH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 4, 2021 | K201309 | ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium | JXL | Substantially Equivalent | Mecta Corporation | accessdata.fda.gov |
| April 26, 2020 | K192834 | MECTA Sigma | QGH | Substantially Equivalent | Mecta Corporation | accessdata.fda.gov |
Compare with other makers
Updated June 4, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.