Data / Medical devices / United States / Omada Health
Omada Health: FDA-registered device maker in S San Fran, CA, United States, 1 510(k) clearance
Omada Health is registered with the FDA (registration 3015236197) in S San Fran, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 19, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015236197
- Address
- 611 Gateway Blvd Ste 120, S San Fran, CA, United States, 94080
- Owner or operator
- Omada Health (10059585)
- Roles
- Complaint file establishment
- First device listed
- February 1, 2019
- Registered through
- 2026
- Brand names listed
- Omada Health Blood Pressure Monitor, Omada Health scale
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Scale, Stand-On, Patient | FRI | 1 | Complaint file establishment | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Complaint file establishment | 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 19, 2013 | K131395 | TRANSTEK BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Scale, Stand-On, Patient
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
Updated June 19, 2013. 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.