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Henley Intl.

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Devices
44

What Henley Intl. makes

Henley Intl. manufactures reusable and disposable surgical drapes, including conductive and laser-compatible variants, as well as reusable and disposable electrodes for electrotherapy and monitoring, such as the JELTRODE and MONOTRODE. The company also produces diathermy units like the CURAPULS 403, fluidotherapy devices such as the Model T11, and computerized exercise and testing systems, including the HYDRA FITNESS Model 311. Additional products include electroconductive media like CHEMPAD™ and specialized medical devices such as the ENDOMED CV405 and OMEGA T200.

Henley Intl.’s products are regulated under FDA 510(k) clearance, with devices classified as Class I and Class II. The company’s offerings are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.

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

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  • Jeltrode Ref K861956

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

  • Am Tm Syrgical Drapes Ref K882643

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

  • Endomed CV405 Ref K880699

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

  • Computerized Testing And Exercise Systems Ref K926313

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

  • Monotrode Cutaneous Electrode Ref K915864

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

  • Model T11 Fluidotherapy Unit Ref K896817

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

  • Chempad(Tm), Electroconductive Media (882.1275) Ref K901630

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

  • Curapuls 403 Diathermy Unit Ref K900189

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

  • True-Trac, Stratus Ref K926316

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

  • Hydra Fitness Model 311 Total Power Ref K926314

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

  • Surgical 'laser' Drape Ref K884231

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

  • Omega T200 Ref K870667

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

  • Dynaphor(Tm) 101, Iontophoresis Device Ref K894549

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

  • Endomed 582 Ref K922020

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

  • Sonopuls 464, Ultrasound Therapy Equipment Ref K872394

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

  • TTS2600 Ref K895334

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

  • Model K210 And K211 Fluidotherapy Units Ref K871802

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

  • Cryotron-UL30 Ref K900419

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

  • Neurotens Ref K896620

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

  • Endomed 433 Ref K870384

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

  • Team-Mc Ii Ref K921828

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

  • Omega T100 Ref K870666

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

  • Sonopuls 591 Ref K922036

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

  • Craig Naso-Gastric Tube Holder Ref K862855

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

  • Sonopuls 590 Ref K920983

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

  • Synaps (Tm) Ref K903828

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

  • Upper Body Exerciser Ref K926279

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

  • Stair Climber Ref K926278

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

  • Peltiertherapy(C) Heat/Cold Treatment Ref K871112

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

  • TTS2800 Ref K895161

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

  • Neurological Diagnostic Devices Ref K943449

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

  • Surgical Duct Clamp (Vine) Ref K882169

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

  • TTS2700 Transcutaneous Electrical Nerve Stimulator Ref K895211

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

  • Curamed 402 Diathermy Unit Ref K861247

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

  • Electroconductive Media Ref K904377

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

  • Exercise Bicycle Ref K926287

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

  • Modified Jeltrode(Tm) Electrodes Deemed Ref K884348

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

  • TTS2500 Ref K895166

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

  • Curapuls 419 Diathermy Unit Ref K861248

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

  • Sonopuls 463, Ultrasound Therapy Equipment Ref K872393

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

  • Vasotrain 447 Ref K871107

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

  • Ems 8100 Ref K895301

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

  • Team-Mc Ref K905672

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

  • Dynatron 438 Ref K870515

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

Rows 1-44 of 44

Frequently asked questions

How many devices does Henley Intl. have in the registry?

The registry currently lists 44 devices for Henley Intl.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Henley Intl.'s devices?

Among its 44 most recently registered devices, Henley Intl. has devices listed in FDA 510(k) (44 devices).

What risk classes do Henley Intl.'s devices fall under?

Among its 44 most recently registered devices, the classes recorded for Henley Intl.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Henley Intl. in the registry?

The most recently registered devices listed for Henley Intl. include JELTRODE, AM TM SYRGICAL DRAPES, ENDOMED CV405 and COMPUTERIZED TESTING AND EXERCISE SYSTEMS.

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