Since they went to the trouble of a 510k I am favoring Licensing partner CCS.
Licensing would be a Partner who purchases the right to manufacture their own device based on BIELs patent.
Although there is a twist with this device. It has two FDA Product Codes. ILX for PEMF and IRT for 'Heated Pad'.
Most OEMs would only need the 'Repackager', 'Relabeler' FDA Registration.
The dual Product Code may have pushed Hi-Dow to a 510k.
Speculation on my part so we will have to see how it all shakes out.
"If prescription only this might be the case?"
Yes ,ILX is the Prescription Only Clearance, No OTC in the US.
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