Data / Medical devices / Electrocardiograph Software For Over-The-Counter Use / United States
FDA-registered makers of Electrocardiograph Software For Over-The-Counter Use in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Electrocardiograph Software For Over-The-Counter Use (product code QDA). 4 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Electrocardiograph Software For Over-The-Counter Use
- Product code
- QDA
- Country
- United States
Makers of Electrocardiograph Software For Over-The-Counter Use in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Apple Inc. | Cupertino, CA, United States | Manufacturer | 2 | October 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| Fitbit LLC | San Francisco, CA, United States | Manufacturer | 1 | September 11, 2020 | 0 | 0 | 0 | api.fda.gov |
| Garmin International, Inc. | Olathe, KS, United States | Manufacturer | 1 | January 12, 2023 | 0 | 0 | 0 | api.fda.gov |
| Whoop, Inc. | Boston, MA, United States | Manufacturer | 1 | April 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| AliveCor | Mountain View, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Masimo Corporation | Irvine, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RR Donnelley-Supply Chain Solutions | Plover, WI, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.