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Re: Jimzin post# 25579

Wednesday, 09/05/2012 4:37:37 PM

Wednesday, September 05, 2012 4:37:37 PM

Post# of 335302
They can today, but if the rulemaking I linked to previously is made final then all PEMF devices approved via 510k, like the Actiband would need to submit a PMA in order to continue marketing the device.