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What do you mean "medical device"?

The Solushin is a class 1 medical device in Australia. Any product making a claim to treat, cure or prevent and injury or illness is classified as a medical device. 

For customers, this ensures that our product is regulated at one of the highest quality and regulatory standards including: quality assurance and medical device manufacturing facilities, and clinical testing to ensure the device works and is safe.

What do you mean by demonstrated in a clinical setting?

The Solushin was used as an investigational device in a double-blinded randomised controlled trial at Sydney Sports Medicine in Sydney, New South Wales, Australia. 

Over a 6-month period, the Solushin demonstrated an ability to reduce the pain severity of medial tibial stress syndrome (commonly referred to as "shin splints") in comparison to the placebo. This study and another on the Solushin's ability to improve ankle range of motion were presented at the 2019 ASICS Sports Medicine Australia Conference.

Where will the solushin be available?

As the Solushin is a medical device, it will be available only to Australian consumers. When the time is right, the team will also register the product with the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to allow American and European consumers to also purchase this product. 

This slower, methodical approach in the medical devices market is imperative to ensure consumers are given a high quality product that is safe and works. 

what happens if the solushin does not fit?

If you have incorrectly selected the wrong size, we can organise a replacement if you notify us within 30 days. It is important to us that the product fits you correctly so you can best take advantage of the product. 

We may ask to review this with you over a video call to ensure your using the product correctly. 


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