Data / Medical devices / United States / Bodytrace
Bodytrace: FDA-registered device maker in San Jose, CA, United States, 1 510(k) clearance
Bodytrace is registered with the FDA (registration 3011912849) in San Jose, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 16, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011912849
- Address
- 2150 N. First St Unit 469, San Jose, CA, United States, 95131
- Owner or operator
- BODYTRACE, INC. (10054678)
- Roles
- Specification developer
- First device listed
- April 20, 2026
- Registered through
- 2026
- Brand names listed
- BT108A, BT108B
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | 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 16, 2019 | K190507 | Full Automatic (NIBP) Blood Pressure Monitor | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 16, 2019. 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.