Soma Flex® is currently marketed as a consumer wellbeing product, allowing it to be introduced without the additional time required for medical device approval. It is made available as an accessible option for women, to purchase privately and confidently, without embarrassment. While the product is not intended or marketed as a medical device, we recognise that secondary benefits may arise through voluntary use and increased bodily awareness. It is because of these secondary benefits that we intend, in the future, to pursue medical device status for Soma Flex®, once appropriate evidence and regulatory requirements are met.