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New development to help treat neuropathy in the feet
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<blockquote data-quote="Ellis79" data-source="post: 1048932" data-attributes="member: 99854"><p>You are probably right where Europe is concerned, but anyone wishing to get a device onto the US market would almost certainly file what is known as a '510(k) pre-market notification' with the FDA, which as the authority's own website states "demonstrates that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to pre - market approval" - in other words, it's not compulsory but worth doing anyway. In the US, at least, that would go a long way towards to qualifying for coverage. I fancy trying out a TENS machine myself, for my back - I often get muscle spasms when getting out of bed in the morning - rather than neuropathy, which, luckily, I haven't suffered too much from recently.</p></blockquote><p></p>
[QUOTE="Ellis79, post: 1048932, member: 99854"] You are probably right where Europe is concerned, but anyone wishing to get a device onto the US market would almost certainly file what is known as a '510(k) pre-market notification' with the FDA, which as the authority's own website states "demonstrates that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to pre - market approval" - in other words, it's not compulsory but worth doing anyway. In the US, at least, that would go a long way towards to qualifying for coverage. I fancy trying out a TENS machine myself, for my back - I often get muscle spasms when getting out of bed in the morning - rather than neuropathy, which, luckily, I haven't suffered too much from recently. [/QUOTE]
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