Data / Medical devices / United States / Thermoworks Inc.
Thermoworks Inc.: FDA-registered device maker in American Fork, UT, United States, 2 510(k) clearances
Thermoworks Inc. is registered with the FDA (registration 3011875311) in American Fork, UT, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 5, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011875311
- Address
- 741 E. Utah Valley Dr, American Fork, UT, United States, 84003
- Owner or operator
- ThermoWorks Inc. (10066033)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- March 31, 2020
- Registered through
- 2027
- Brand names listed
- ThermoWorks WAND, ThermoWorks WAND Blue, ThermoWorks WAND Cinical, ThermoWorks WAND Mini
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Repackager or relabeler, 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 |
|---|---|---|---|---|---|---|
| June 5, 2024 | K240648 | Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) | FLL | Substantially Equivalent | Radiant Innovation, Inc. | accessdata.fda.gov |
| July 17, 2012 | K121428 | NON-CONTACT CLINICAL THERMOMETER | FLL | Substantially Equivalent | Radiant Innovation, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 5, 2024. 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.