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DiscussionJust Diagnosed with Small Fiber Neuropathy
Neuropathy | Last Active: Aug 12 10:26am | Replies (236)Comment receiving replies
Replies to "The wording is actually "FDA cleared" and "covered by Medicare and major insurance" is on Dr...."
@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.