Data / Medical devices / United States / Somatics, LLC
Somatics, LLC: FDA-registered device maker in Venice, FL, United States, 5 510(k) clearances
Somatics, LLC is registered with the FDA (registration 1420295) in Venice, FL, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 25, 1999. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1420295
- Address
- 720 Commerce DR Unit 101, Venice, FL, United States, 34292
- Owner or operator
- SOMATICS, LLC (1420295)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 19, 2007
- Registered through
- 2026
- Brand names listed
- EEDS, EMGD & EMGS, EPAD, Thymatron, VENTIL-A
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Block, Bite | JXL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder | QGH | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 25, 1999 | K992269 | VENTIL-A ORAL PROTECTOR | JXL | Substantially Equivalent | Somatics, Inc. | accessdata.fda.gov |
| October 26, 1995 | K945120 | THYMATRON 2000 ELECTROCONVULSIVE SYSTEM | QGH | Substantially Equivalent | Somatics, Inc. | accessdata.fda.gov |
| March 14, 1989 | K890710 | DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS | GXY | Substantially Equivalent | Somatics, Inc. | accessdata.fda.gov |
| September 27, 1988 | K882809 | THYMAPAD | GXY | Substantially Equivalent | Somatics, Inc. | accessdata.fda.gov |
| November 3, 1986 | K864181 | SOMATICS MOUTH GUARD (BITE BLOCK) | JXL | Substantially Equivalent | Somatics, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 25, 1999. 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.