"The technology and functionality of our current products were co-designed by our new supplier in Taiwan, which, as discussed below, is the manufacturer and the assignor to us of the requisite U.S. governmental pre-marketing approvals for them. We designed the housing of our products"
Sounds as though SIMH just designed the cover, to make it look a bit different from others. And the manufacturer already had US approval that SIMH is making use of.
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