Data / Medical devices / United States / TF Health Corp.
TF Health Corp.: FDA-registered device maker in Phoenix, AZ, United States, 1 510(k) clearance
TF Health Corp. is registered with the FDA (registration 3012066447) in Phoenix, AZ, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 25, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012066447
- Address
- 6161 E Mayo Blvd, Phoenix, AZ, United States, 85054
- Owner or operator
- TF Health Corp. (10079353)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- December 2, 2020
- Registered through
- 2026
- Brand names listed
- Breezing Med
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Oxygen-Uptake | BZL | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| September 25, 2020 | K200076 | Breezing Med | BZL | Substantially Equivalent | Tf Health Co. | accessdata.fda.gov |
Compare with other makers
Updated September 25, 2020. 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.