Data / Medical devices / United States / Welwaze Medical, Inc.
Welwaze Medical, Inc.: FDA-registered device maker in Doral, FL, United States, 1 510(k) clearance
Welwaze Medical, Inc. is registered with the FDA (registration 2247290) in Doral, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 17, 1984. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2247290
- FEI number
- 1000129707
- Address
- 2800 NW 105 Ave, Doral, FL, United States, 33172
- Owner or operator
- Welwaze Medical, Inc (10031476)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- February 3, 2010
- Registered through
- 2026
- Brand names listed
- Celbrea TMD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use) | KYA | 1 | Complaint file establishment, 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 17, 1984 | K832989 | BREAST THERMAL ACTIVITY INDICATOR | KYA | Substantially Equivalent | Bcsi Laboratories, Inc. | accessdata.fda.gov |
Updated January 17, 1984. 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.