Data / Medical devices / United States / Zenith Technical Innovations, LLC
Zenith Technical Innovations, LLC: FDA-registered device maker in Gurnee, IL, United States, 5 510(k) clearances
Zenith Technical Innovations, LLC is registered with the FDA (registration 3014834638) in Gurnee, IL, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 21, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014834638
- Address
- 1396 Saint Paul Ave, Gurnee, IL, United States, 60031
- Owner or operator
- Zenith Technical Innovations, LLC. (10058299)
- Roles
- Manufacturer
- First device listed
- August 17, 2018
- Registered through
- 2026
- Brand names listed
- Therm-X, Therm-X (Therm-X Home and Therm-X AT)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | 2 | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Water Circulating | ILO | 2 | Manufacturer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 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 21, 2024 | K240125 | Therm-X (Home); Therm-X (AT) | JOW | Substantially Equivalent | Zenith Technical Innovations | accessdata.fda.gov |
| July 27, 2023 | K231912 | Therm-X | IRP | Substantially Equivalent | Zenith Technical Innovations | accessdata.fda.gov |
| February 28, 2020 | K193550 | Therm-X | IRP | Substantially Equivalent | Zenith Technical Innovations | accessdata.fda.gov |
| May 10, 2019 | K190854 | Therm-X | IRP | Substantially Equivalent | Zenith Technical Innovations | accessdata.fda.gov |
| August 3, 2018 | K181149 | Therm-X Pro, Therm-X AT, Therm-X Pro Athlete | IRP | Substantially Equivalent | Zenith Technical Innovations | accessdata.fda.gov |
Compare with other makers
- All makers of Sleeve, Limb, Compressible
- All makers of Massager, Powered Inflatable Tube
- All makers of Pack, Hot Or Cold, Water Circulating
Updated June 21, 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.