Data / Medical devices / United States / Trinity Guardion, Inc.
Trinity Guardion, Inc.: FDA-registered device maker in Batesville, IN, United States, 1 510(k) clearance
Trinity Guardion, Inc. is registered with the FDA (registration 3009276553) in Batesville, IN, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 1, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009276553
- Address
- 4 S Park Ave Suite 204, Batesville, IN, United States, 47006
- Owner or operator
- Trinity Guardion, Inc (10037075)
- Roles
- Manufacturer
- First device listed
- March 3, 2023
- Registered through
- 2026
- Brand names listed
- Soteria Bed Barrier, Trinity Guardion
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mattress And Bed Deck Cover (Medical Purposes) | QTV | 1 | 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 |
|---|---|---|---|---|---|---|
| September 1, 2022 | K201876 | Soteria Bed Barrier | QTV | Substantially Equivalent | Trinity Guardion | accessdata.fda.gov |
Compare with other makers
Updated September 1, 2022. 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.