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Just Diagnosed with Small Fiber Neuropathy

Neuropathy | Last Active: Aug 12 10:26am | Replies (236)
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@johnbishop

@dont and others...
What does 'FDA cleared' mean? --- Class II and Class I medical devices are usually "cleared" by the FDA, which means the manufacturer can demonstrate that their product is "substantially equivalent to another (similar) legally marketed device" that already has FDA clearance or approval. Those already-cleared products are called a predicate.

Hope it works for you but I'm a bit skeptical.

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Replies to "@dont and others... What does 'FDA cleared' mean? --- Class II and Class I medical devices..."
sunnyflower | @sunnyflower | Oct 9, 2020

Thx John. After reading your post I had to know what FDA "approved" means. Here is what I found, FDA "approved" means "the agency has determined that the benefits of the product outweigh the known risks for the intended use." Warm regards, Sunnyflower

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sunnyflower | @sunnyflower | Oct 9, 2020

Ooops, forgot to include the names you included in your response so guys, please see my reply to John's post about FDA "cleared". Warmest wishes, Sunnyflower @dont @jesfactsmon

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