Saint-maur-des-fosses, France

  • Observational Prospective PMCF Study to Confirm Performance and Safety of Intelect® Devices in Real World

    This clinical investigation is a post-market, real word, international, multi center, prospective, observational study to confirm the safety and performance of the Chattanooga Intelect® when used in accordance with their approved intended use, to comply with Medical Device Regulation (EU) 2017/745 (MDR) Article 61 and Part B of Annex XI.

    Phase

    N/A

    Span

    95 weeks

    Sponsor

    DJO UK Ltd

    Serris

    Recruiting

  • Performance and Safety of LightForce® Therapy Lasers on Shoulder Soft Tissue Inflammation Pain Reduction

    This clinical investigation is a post-market, International, multi center, prospective, randomized, sham controlled, single blind study to assess the effectiveness of LightForce® Therapy Lasers and to collect PMCF data on the safety and performance of LightForce® Therapy Lasers, when used in accordance with its approved labeling, to comply with Medical Device Regulation (EU) 2017/745 (MDR) Article 61 and Part B of Annex XI.

    Phase

    N/A

    Span

    97 weeks

    Sponsor

    DJO UK Ltd

    Serris

    Recruiting

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