Tdk Corp.
Country not established
- Devices
- 6
What Tdk Corp. makes
TDK Corporation manufactures disposable ECG electrodes, including single-use and reusable types for monitoring heart activity. The product line includes standard and mini-sized electrodes, such as the MEL-20 series for general use and the MEL-08 series for pediatric or compact applications. These electrodes are designed for adhesive attachment to the skin and are used in conjunction with electrocardiogram (ECG) devices.
The company’s ECG electrodes are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records in the U.S. registry. The products are listed under the FDA’s device identification system for electrocardiographic electrodes.
Catalogue
Tdk Electrode Mel-20-1, Mel-20-3, Mel-20-5 Ref K882904
Regimes: 510(k) Registry: 510(k)Mel-16-1, Mel-16-3 & Mel-16-5 Tdk Ecg Electrodes Ref K863369
Regimes: 510(k) Registry: 510(k)Tdk Ecg Electrode Mel-08-09 & -11 Ref K854596
Regimes: 510(k) Registry: 510(k)Tdk Ecg Electrode Mel-10 Ref K870834
Regimes: 510(k) Registry: 510(k)Tdk Ecg Electrode, Mel-10l Ref K883643
Regimes: 510(k) Registry: 510(k)Tdk Ecg Electrode Mel-08 Ref K833899
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Tdk Corp. have in the registry?
The registry currently lists 6 devices for Tdk Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tdk Corp.'s devices?
Among its 6 most recently registered devices, Tdk Corp. has devices listed in FDA 510(k) (6 devices).
What risk classes do Tdk Corp.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Tdk Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tdk Corp. in the registry?
The most recently registered devices listed for Tdk Corp. include TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5, MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES, TDK ECG ELECTRODE MEL-08-09 & -11 and TDK ECG ELECTRODE MEL-10.