Data / Medical devices / Canada / Thermotex Therapy Systems Ltd.
Thermotex Therapy Systems Ltd.: FDA-registered device maker in CALGARY Alberta, Canada, 1 510(k) clearance
Thermotex Therapy Systems Ltd. is registered with the FDA (registration 9615330) in CALGARY Alberta, Canada. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 28, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9615330
- FEI number
- 3002316112
- Address
- 15, 6115 - 4 ST. S.E., CALGARY Alberta, Canada, T2H 2H9
- Owner or operator
- THERMOTEX THERAPY SYSTEMS LTD. (9032260)
- Roles
- Manufacturer
- First device listed
- January 19, 2011
- Registered through
- 2026
- Brand names listed
- Thermotex, Thermotex Heat Therapy Systems, Thermotex Therapy Systems
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 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 |
|---|---|---|---|---|---|---|
| January 28, 2010 | K092589 | THERMOTEX PLATINUM SYSTEM | ILY | Substantially Equivalent | Eas Consulting Group, LLC | accessdata.fda.gov |
Compare with other makers
Updated January 28, 2010. 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.