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Friday, February 02, 2024 12:34:28 PM
Regarding the bruise example: Maybe the skin heals faster directly under the wire. Maybe the edge of bruises heal faster with or without an ActiPatch because there's less damage to the skin and body on the edge of a bruise. Regardless -- what has that got to do with BIEL's claim of "50% more power?"
Maybe it's true that changing the shape to a narrower rectangle increases healing of an incision wound, but the patient can accomplish that with the existing ActiPatch or RecoveryRx product simply by applying tape or rubber bands to the antenna, eliminating the need for (and therefore the marketability of) a new product and eliminating the need for a new 510(k).
Let's summarize. What exactly is the "50% more power" device? RecoveryRxtra or whatever it's called -- how is it different from the existing products?
In post 325408 you said it was the length of the antenna, but that is proven wrong by BIEL's 510(k) documentation.
In post 326204 you said it was the shape of the antenna, but fail to explain why that would require a new 510(k) or even a new device.
Now in 326212 it seems we're back to the length of the antenna.
I guess we'll have to wait for the company to break their silence.
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