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Re: wyattiamrolling post# 42181

Wednesday, 08/27/2014 10:57:06 AM

Wednesday, August 27, 2014 10:57:06 AM

Post# of 328507
Open the link wyatt found and clik on
Total Product Life Cycle (TPLC) TPLC Product Code Report

Then clik on each product and they all mention therapeutic deep heat, yet they are all Diathermy Shortwave devices. Are the applying party or parties using current Regs to get early applications for Class II into the FDA system using the "Substantially equivalent" window?

Is this area of therapy one of the types that Dr. Kotak was describing when he mentioned there are many future applications of BIEL's technology? BIEL's light weight and portability are distinct advantages that may be applicable in many treatment areas. Hmmm.