Phase II year
2022
(last award dollars: 1699961580)
Phase II Amount
$1,099,944
The innovative product is for neck/back pain and is based on hardware (electrodes, micro-electronics, controller with on/off switch, and alkaline batteries) technology developed with software (algorithms and firmware). The solution embodies an innovative method utilizing functional electrical stimulation (FES). This product is specifically designed for: Neck/back pain during operational conditions and Flight environment on military equipment, especially naval environments. Key goals include 1) design and perform human factors engineering for the textile shirt liner as a system with 2 16 embedded electrodes, one wire, and one controller; 2) present a design architecture report describing the FES electrodes, micro-electronics, alkaline batteries, and a controller embedded into the shirt liner; 3) create and present design architecture for algorithms and firmware providing on-demand ("set it" and "forget it") with an on/off controller; 4) research and identify relevant flight safety requirements, research and identify FDA guidance documents and rules to determine if the solution will require no submission, FDA Clearance application, or FDA Approval (510k) application; and 5) research human subject protocol, prepare IRB (institution review board) submission and achieve IRB approval, and implement IRB study where human subjects wear proposed solution.
