Tuesday, October 06, 2015 9:14:51 AM
By then the FDA will have to respond to the 510K anyway and the final classification should be done as the 510K forces their hand.
there are no similar priced products in the market
no one has OTC clearance for PEMF devices. TENS units do not heal only numb the pain.
icy hot patches and creams do help but again treat the pain not the healing necessary in the same focussed way as Actipatch.
Its been many years (7?) but so what buy in now it wont go below 0.0004 that is where it was when the draft reclassification rule was proposed.
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