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Electromed Intl., Ltd.

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Devices
23

What Electromed Intl., Ltd. makes

Electromed Intl., Ltd. manufactures electrotherapy devices, including TENS (transcutaneous electrical nerve stimulation) window electrodes and constant potential X-ray generators like the EDEC 80. Their portfolio also includes cardio-respiratory monitors such as the CR-1 and CR-2 models, as well as electrodiagnostic equipment like the EDEC 2000 and EDEC 90C. Additional products include reading stations (e.g., VIEW READING STATION) and communication interfaces (e.g., VIEW COM) for medical diagnostics.

The company’s devices are classified under FDA regulations as Class I and Class II, with submissions recorded in the 510(k) clearance pathway. These products are listed under U.S. jurisdiction, and the manufacturer is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue23

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  • Edec 2000 Ref K852908

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Edec 90C Ref K875342

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • View Reading Station Ref K003688

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Edec 60 R/F Ref K875341

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Em Tens Window Electrodes Ref K864032

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Edec 60R Ref K880050

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Cadio-Respiratory Monitor #cr-2 Ref K823312

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • View Com Ref K990759

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cardio-Respiratory Monitor Model Cr-1 Ref K821959

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Edec-100 Ref K843443

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Edec 80 Constant Potential X-Ray Generator Ref K870851

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Em Electrode Ref K853774

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Em Iii Disposable Electrode Ref K863845

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Edec 50C Constant Potential X-Ray Generator Ref K871145

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Em Diagnostic Ecg Electrode Ref K862746

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Em Ii Disposable Electrode Ref K863540

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Em Ii Stress Test Electrode Ref K863584

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Em Stress Electrode Ref K860827

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • View Nt Ref K000474

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Infant Caridac Monitor Ref K812674

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cd-R Station And Vrs-2000 Ref K974255

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Compact-X Ref K950694

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • View Archiving Station Ref K971176

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-23 of 23

Frequently asked questions

How many devices does Electromed Intl., Ltd. have in the registry?

The registry currently lists 23 devices for Electromed Intl., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Electromed Intl., Ltd.'s devices?

Among its 23 most recently registered devices, Electromed Intl., Ltd. has devices listed in FDA 510(k) (23 devices).

What risk classes do Electromed Intl., Ltd.'s devices fall under?

Among its 23 most recently registered devices, the classes recorded for Electromed Intl., Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Electromed Intl., Ltd. in the registry?

The most recently registered devices listed for Electromed Intl., Ltd. include EDEC 2000, EDEC 90C, VIEW READING STATION and EDEC 60 R/F.

Generated automatically from registry data and not verified by a human reviewer.