That is why BIEL took the time to go through the Pre-Submission Review process. They showed the FDA what they would be submitting and got feedback on any changes that were needed.
It is not a guarantee of a problem free Clearance with the initial 510k Submission but it has to increase the odds significantly.
The other major positive for this Clearance is that the FDA is reviewing the same device that was Cleared for Foot and Knee use in 2017. They know the safety is 100%, no injuries or side effects ever. The mechanism of action was established, no time wasted there. The OTC issue was debated and approved with a new Product Code, PQY, for the ActiPatch.
BIEL is giving the FDA what they requested before Full Body use could be awarded, proof of efficacy on a third body part, the Back.
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