Data / Medical devices / United States / Smwmed Inc.
Smwmed Inc.: FDA-registered device maker in San Diego, CA, United States, 1 510(k) clearance
Smwmed Inc. is registered with the FDA (registration 3046311522) in San Diego, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 23, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3046311522
- Address
- 10180 Telesis Court, Suite 155, San Diego, CA, United States, 92121
- Owner or operator
- Smwmed Inc. (10095826)
- Roles
- Complaint file establishment
- First device listed
- May 6, 2026
- Registered through
- 2026
- Brand names listed
- Rhythm Master ECG Patch (Models: HM-15BB-AX, HM-15BW-AX)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Recorder, Magnetic Tape, Medical | DSH | 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 |
|---|---|---|---|---|---|---|
| April 23, 2026 | K252389 | Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) | DSH | Substantially Equivalent | Smwmed, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 23, 2026. 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.