No, IMO BIEL, specifically Dr. Koneru, designed the PEMF system and BIEL Licensed the use of that design to Hi-Dow, no manufacturing by BIEL. If BIEL does the mfg you are back to a OEM contract.
There is a lot going on in that little control unit, needs to be an integrated build.
https://www.truestim.com/shop/knee-wrap-genesys-pemf/
We never saw a notification from BIEL of the SAI Deal and yet the FDA Establishment Registration & Device Listing Database has had them listed for 6 months as a Repackager under BIEL's 510K 192234.
My only guess as to why is that Non Fully Reporting to SEC companies may not have the same Material Event rules as the Fully Reporting companies.
There is a lot going on in that little control unit, needs to be an integrated build.
https://www.truestim.com/shop/knee-wrap-genesys-pemf/
We never saw a notification from BIEL of the SAI Deal and yet the FDA Establishment Registration & Device Listing Database has had them listed for 6 months as a Repackager under BIEL's 510K 192234.
My only guess as to why is that Non Fully Reporting to SEC companies may not have the same Material Event rules as the Fully Reporting companies.
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