"Not the same animal?" what? You submit a 510(k) for a Class II device to get FDA clearance to sell it. If the 510(k) is approved, the FDA grants permission to market the device. It absolutely IS the same animal, like a kitten and a cat are the same animal.
The current Chinese manufacturer, Shenzhen CICD Technologies Ltd,, doesn't have to file anything. They are already registered with the FDA to manufacture the ActiPatch. Shenzhen CICD wouldn't be selling the device to consumers, they'd be supplying the new entity that filed the expedited 510(k). What part of THAT don't you get?
Why did you bold "current regulations and guidelines?" Use the current 510(k) form and process and that is done.
BIEL has five FDA clearances but anyone wanting to sell the thing needs just one: full-body OTC.
"A US company having their product made in China is quite different from a Chinese company making a knockoff-off to sell here." So what? BIEL is already the US company having their product made in China by Shenzhen CICD Technologies Ltd. A new entity would buy that same device from that same manufacturer. It's not a knock-off, IT IS THE ACTIPATCH. It's what KT Tape sells.
The entity that wants to sell the Shenzhen CICD device in the USA does NOT have to prove safety or efficacy in a 510(k) because that's not required in a 510(k). Biotechs include safety data and efficacy data only to prove substantial equivalence. The new company's device WOULD BE THE ACTIPATCH with a different name so substantial equivalence is a slam dunk. What part of THAT don't you get?
Nobody will merge with BIEL. There's no reason for an entity to take on that debt. BIEL has no patents and no meaningful sales channels so they have nothing to offer a merging partner except the failed brand name "ActiPatch."
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