38 of 41 people found the following review helpful
Amazon Verified Purchase(What's this?)I am a distance runner...suffer from chronic short hamstrings/strains. Would drive to physical therapy or beg to borrow their huge/expensive ultrasound machine & TENS unit to use at home. Physical therapy works, and is essential to fast/effective healing---esp. when training for a big race...w/ this little ultrasound, I can rehab quickly at home....and prevent future injuries which keeps me running and enjoying the sport rather than nursing an injury and dealing w/ pain. Love it! The value and customer service [...] was above any expectations! Highly recommend this product! Laura
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Showing 1-4 of 4 posts in this discussion
Initial post: Dec 10, 2008 2:32:22 PM PST
Be careful with this product!! It does not have FDA approval for marketing or sale in the USA! After speaking with an FDA consumer representative, we reviewed the website together over the phone for over 30 minutes. She attempted to cross-reference and verify the product or the selling company with the FDA database and she could not find anything that indicated it was permitted for sale in the USA under FDA guidelines for radiation emitting devices. After speaking with a MendMeShop representative, she did say that it had not even been submitted for review or approval by the FDA. Not good! This doesn't reflect well upon Amazon.com either for allowing a non-FDA approved device to be sold via their store front.
In reply to an earlier post on Feb 3, 2009 9:33:45 AM PST
Who cares about FDA these days. It takes them forever to approve things and after that a ton of drugs are withdrawn from the market anyway. The important things is that the device works. That's what matters.
In reply to an earlier post on Jul 1, 2010 7:09:34 AM PDT
Last edited by the author on Jul 1, 2010 7:10:27 AM PDT
Michael A. Johnson says:
While what you are saying is true you are confusing some things. The importance of submittal to the FDA is not necessarily for just the issue of safety. The FDA is a regulatory body. In such if you claim that your product is a medicine as in it treats or cures an ailment then it must go through the FDA. The cost of doing so in a manner to get approved means a lot of companies don't submit to the FDA. As an example of this most over the counter herbs you see are not FDA approved. Why you may ask? It is because they don't want to spend the money for clinical trials to prove their statements. Despite the fact that a known chemical or herb may have known properties you still have to do clinical trials to prove you product is doing what you claim. Therefore you will notice the herbs only use a particular type of language. They don't say cures anything. They will say things such as known to or has known benefits etc etc. The same is most likely true of this product. Works for some and doesn't work for other however doing clinical trials to prove it is just not worth the money to them. The technology is known and shown to work. Bigger companies use ultrasound and their products have gone through the FDA.
Now as this is a Canada based company they fall outside of the FDA's jurisdiction. They ship to you from outside of the US. They therefore get to use the words treat and cure without ramifications. Again you should always take care when buy products from outside the US but just because it is not submitted to the FDA does not mean the product is bad or dangerous. It just means it hasn't been approved by the FDA and thus you are limited on some of the protection offered by such an approval.
Posted on Feb 28, 2013 9:44:28 AM PST
It's 2013 and I'm still using my little Ultrasound! It works well and has kept me running....great product!
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