Similar to Davids’s situation I was in the same class and our final project was a novel prosthetic arm. Our proposal was the development of new types of soft robotic structures, especially materials/methods for the fabrication of such robots, involving biomaterial science and robotics. The goal was to increase current standards in limited range of motion and create a more natural integration point for the soft robotic implantation. We thought that the regulation within this would be at the very least a Class II Device since there were predicate prosthetics and this was similar to those and with the electronic and mechanical component this would have a greater risk associated than a Class I Device. To our surprise while researching and putting together the proposal the classification for this device turned out to be Class I General Controls.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=1&DeviceName=&ProductCode=&ThirdParty=&DeviceClass=1&SUBMISSION_TYPE_ID=4&GMPExempt=Y&Panel=&RegulationNumber=890.3420&PAGENUM=10&SortColumn=DeviceName