IV. Testing Requirements

Due to the electrical stimulation aspect of our device, testing for quality, safety and effectiveness is a crucial step before the product can go on the market. Different aspects of the NeuroAcuStim aid’s design will have to be tested: the electrical outputs must be measured, especially at the needles to make sure delivered currents and voltages are safe and within therapeutic limits, and current must be measured at different points on the device to make sure the insulating materials protect from electricity. The device will also have to be subject to durability testing to ensure it doesn’t break or damage under normal conditions. This first round of testing determines if the device is safe for human use. The second round of testing involves clinical trial(s) of patients using the NeuroAcuStim compared to patients using traditional and no therapy. To test for effectiveness, the patients’ motor and sensory function will be measured before and after the study and results will be compared. If there is a significant improvement in motor & sensory function in patients using our device compared to improvement with those taking traditional therapy or no therapy, the NeuroAcuStim device has proven its effectiveness and safety and can go on the market.