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Staodynamics, Inc.

United StatesFDA applicant, unverified

Devices
14

What Staodynamics, Inc. makes

Staodynamics, Inc. manufactures transcutaneous electrical nerve stimulation (TENS) devices, electrical muscle stimulators (EMS), and related electrodes. Products include portable stimulators like the PLS Mini and Portable Pulse Galvanic Stimulator, as well as TENS units such as the TENS 4100 and TENS 4500. Sterile electrodes (e.g., Staoderm Sterile and TENS-Aid Sterile) and accessories like the Point Locator Stimulator are also part of the portfolio.

The company’s devices are classified under Class I and Class II regulations, with several listed via the FDA’s 510(k) pathway. These products are intended for pain management, muscle stimulation, and postoperative recovery applications. The manufacturer is based in the United States.

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

Catalogue14

Newest first, rows 1-14 of 14

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  • Insight Ref K811345

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

  • Electrical Muscle Stimulator (Ems) Ref K800068

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

  • Tens Device Ref K813098

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

  • Tens-Aid Premium Electrodes Ref K843964

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

  • Electrodes, Staoderm Sterile Ref K790542

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

  • Staodyn Ems/Plus Ref K832988

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

  • Portable Pulse Galvanic Stimulator Ref K791087

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

  • Point Locator Stimulator Ref K792529

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

  • Pls Mini Ref K792501

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

  • Tens-Aid Sterile Electrodes For Post-Op Tens Ref K852298

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

  • Tens 4100 Ref K792502

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

  • Tens 4500 Ref K792474

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

  • Stao-Hotpack Ref K790904

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

  • 10D (Tens Device) Ref K813283

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

Rows 1-14 of 14

Frequently asked questions

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

The registry currently lists 14 devices for Staodynamics, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Staodynamics, Inc.'s devices?

Among its 14 most recently registered devices, Staodynamics, Inc. has devices listed in FDA 510(k) (14 devices).

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

Among its 14 most recently registered devices, the classes recorded for Staodynamics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Staodynamics, Inc. include INSIGHT, ELECTRICAL MUSCLE STIMULATOR (EMS), TENS DEVICE and TENS-AID PREMIUM ELECTRODES.

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