Data / Medical devices / Electrocardiograph Software For Over-The-Counter Use
Electrocardiograph Software For Over-The-Counter Use (QDA): 13 FDA-registered makers in 6 countries
13 establishments in 6 countries are registered with the FDA to make Electrocardiograph Software For Over-The-Counter Use (product code QDA, Class 2, 21 CFR 870.2345). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on June 15, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QDA
- Device class
- 2
- Regulation
- 870.2345
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Japan | 2 |
| South Korea | 1 |
| France | 1 |
| China | 1 |
| Malaysia | 1 |
Makers of Electrocardiograph Software For Over-The-Counter Use
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Samsung Electronics Co., Ltd. Mobile eXperience Business | Suwon-si Gyeonggi, South Korea | Manufacturer | 3 | August 2, 2024 | 0 | 0 | 0 | api.fda.gov |
| 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 |
| Withings | Issy-les-Moulineaux Ile-de-France, France | Manufacturer | 1 | June 15, 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 | |
| Omron Healthcare Co., Ltd. | MUKO Kyoto, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OMRON HEALTHCARE Co., Ltd. Matsusaka Factory | Matsusaka Mie, Japan | Contract manufacturer | 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 | |
| Ryder Electronics (shenzhen) Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecan Cdmo Solutions PN Sdn. Bhd. | Penang Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 15, 2025. 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.