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Re: rrao11 post# 30340

Saturday, 04/25/2020 10:35:49 AM

Saturday, April 25, 2020 10:35:49 AM

Post# of 36365
FDA class II Substantially changed devices will need to be reviewed before marketing clearance will be issued by the fda...
(simply put can’t market the device due to device applied application time/ AI software changes are re approved )
Your Probably aware the iT Bra went through technology upgrades, these changes substantially changed the
efficacy for the better, but still need FDA review.
This is why their website states-“The product is not currently available for sale in the United States.“
& Cyrcadia Asia states ”FDA Class II clearance issued with further clearances in process.”
Will Covid-19 hasten or impede the FDA & US continued trial...will see !