Skip to content

Staodyne, Inc.

United StatesFDA applicant, unverified

Devices
9

What Staodyne, Inc. makes

Staodyne, Inc. manufactures transcutaneous electrical nerve stimulation (TENS) devices, including portable stimulators like the STAODYN MAXIMA III and MAXIMA I, as well as disposable and reusable cutaneous electrodes (e.g., STERILE TREATMENT ELECTRODE, TPK CUTANEOUS ELECTRODE). The company also produces nerve stimulators such as the MODEL 19 STIMULATOR and specialized units like the STAODYN TUWAVE and STAODYN EMS+2, designed for pain management and neuromuscular applications.

These devices are classified as Class II under FDA regulations and are authorised via 510(k) clearance. The company’s products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue9

Newest first, rows 1-9 of 9

  • Staodyn Maxima Iii Ref K930865

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

  • Sterile Treatment Electrode Ref K941923

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

  • Tpk Cutaneous Electrode Ref K931925

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

  • Staodyn Tuwave Ref K921668

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

  • Staodyn EMS+2 Ref K926510

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

  • Maxima I Ref K931424

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

  • Tens Ref K921110

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

  • Model 19 Stimulator, Nerve, Transcutaneous Ref K925898

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

  • Varapulse-2 Ref K952680

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

Frequently asked questions

How many devices does Staodyne, Inc. have in the registry?

The registry currently lists 9 devices for Staodyne, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Staodyne, Inc.'s devices?

Among its 9 most recently registered devices, Staodyne, Inc. has devices listed in FDA 510(k) (9 devices).

What risk classes do Staodyne, Inc.'s devices fall under?

Among its 9 most recently registered devices, the classes recorded for Staodyne, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Staodyne, Inc. in the registry?

The most recently registered devices listed for Staodyne, Inc. include STAODYN MAXIMA III, STERILE TREATMENT ELECTRODE, TPK CUTANEOUS ELECTRODE and STAODYN TUWAVE.

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