The project is about a power assist device (PAD) that can be adapted to different types of manual wheelchairs with the aim of facilitating manual propulsions through a slower deceleration of the thrusts resulting from the traction of the PAD. This approach prevents upper extremity musculoskeletal injuries for manual wheelchair users. The DAP would be connected via IoT to allow a clinician to remotely track the rehabilitation of patients based on their travel distance and propulsion quality data. The clinician would then be able to take action to correct deficiencies in manual propulsion quality and ensure proper use of the manual wheelchair. The technology is at TRL 7 level, the proof of concept and pre-clinical evaluation having been completed.
The project aims to achieve the FDA-recognized standard [AAMI TIR57:2016] to meet the regulatory authorities’ criteria for medical device IoT cybersecurity.
The project is also targeting [FDA 21 CFR 820 Class II], [2017-745 MDR Class I], [ARGMD-Australia Medical Device Class I] and [Health Canada Class I medical device] approvals that are required for its commercialization as a medical device. As part of its commercialization, the DAP also needs to meet the FCC, IEC 62304, IEC 62133, IEC 60601, ISO7176 and EN12184 norms.