No doubt abut it DL!! Anyone that has seen ALL the mistakes made and promises unfulfilled by this inept management, would have to be crazy to be certain that these clearances will come true. 2 steps forward, 1 step back would be welcome from this leadership. We were getting 1 step forward, 2 steps back throughout the 10 years I have been here. BUT by getting that acknowledgement of products by FDA with their 2 clearances, the total picture, at least to myself, looks entirely different. USA FDA clearance is HUGE. Our products are in 'their heads' and known to be effective and safe. Now we have to make sure that the trials are adequate in showing the same for future products. Ball in company's court. Will all go smooth due to that, for more clearances from this company? I think that was answered, with AGAIN NOT getting clearance for BACK, all muscle and joint pain from FDA. WHY? Most undoubtedly more inept management in providing insufficient data for those clearances. History shows this is ON management and OUR CEO GOING CHEAP AGAIN! Been listening to this broken record repeatedly is getting on my nerves. Time for that ONE step forward AGAIN with the submitting of these two 510k's and praying for no more 2 steps back.
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