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

Observational Prospective Post Market Clinical Follow-up (PMCF) Study to Confirm the Performance and Safety of the Chattanooga Intelect® Devices in Real World Use

DJO UK Ltd (ENOVIS) is conducting this study to confirm the performance and safety of the Chattanooga Intelect® devices in real world use. This study will record post market clinical data on the use of a number of MDR-CE marked devices that are part of the Chattanooga Intelect® device family to ensure the continued acceptability of the benefit-risk ratio, and to identify possible systematic misuse or off-label use of the devices (Intelect® Mobile 2 Combo, Intelect® Mobile 2 Ultrasound, Intelect® Mobile 2 Electrotherapy (Stim), Intelect® Transport 2 Combo and Intelect® Transport 2 Ultrasound).

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.

Inclusion Criteria:

1. Patients with musculoskeletal and skeletal muscle deficit disorders assigned to be treated with any of the Intelect® devices according to the current clinical practice at the selected sites and based on the opinion of the Investigator.
2. Patient male or female with age ≥18 years old.
3. Patient able to provide written informed consent. For France only: To be affiliated to the social security system or to be beneficiary of such system

Exclusion Criteria:

1. Patients participating in another clinical study or who have completed a clinical study less than 30 days prior to enrollment.
2. Patients who for any reason e.g. significant co-morbidities or other reasons, are considered by the Investigator unsuitable for study participation.