Our device will be classified as an FDA class II device. Being a class II device we will have to perform a clinical trial and submit a 510K. We plan on doing a year long clinical trial to validate our device and use the results to get approval from the FDA to sell our device. We also plan on using a predicate medical device to fast track our 510K approval. We anticipate from the start of the clinical trial to approval of 510K from the FDA to late approximately a year and a half.
