Data / Medical devices / Taiwan / QT Medical, INC. Taiwan Branch
QT Medical, INC. Taiwan Branch: FDA-registered device maker in New Taipei City, Taiwan, 5 510(k) clearances
QT Medical, INC. Taiwan Branch is registered with the FDA (registration 3014982325) in New Taipei City, Taiwan. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 29, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014982325
- Address
- 14F.-8, No. 2, Jian 8th Rd., Zhonghe Dist., New Taipei City, Taiwan, 235
- Owner or operator
- QT MEDICAL, INC (10058094)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- July 15, 2018
- Registered through
- 2027
- Brand names listed
- ECG Recorder (PCA 300), PCA 500, PCA 500+, PCA-A100 QHeart Cable L, PCA-A110 QHeart Cable Z, PCA-A120 L QHeart Cable GL, PCA-A120 S QHeart Cable GS, PCA-A130 QHeart Cable P and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Complaint file establishment, Manufacturer, 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 29, 2026 | K260250 | QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) | DPS | Substantially Equivalent | QT Medical, Inc. | accessdata.fda.gov |
| December 6, 2023 | K233521 | QT ECG (QTERD100) | DXH | Substantially Equivalent | QT Medical, Inc. | accessdata.fda.gov |
| September 26, 2022 | K220795 | QT ECG | DXH | Substantially Equivalent | QT Medical, Inc. | accessdata.fda.gov |
| June 3, 2021 | K200722 | PCA-C1 series Patient Cable | DSA | Substantially Equivalent | QT Medical, Inc. | accessdata.fda.gov |
| May 4, 2018 | K180157 | QT ECG | DXH | Substantially Equivalent | QT Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
- All makers of Cable, Electrode
- All makers of Electrocardiograph
- All makers of Cable, Transducer And Electrode, Patient, (Including Connector)
- All makers of Electrode, Electrocardiograph
Updated September 29, 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.