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09:46
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Originally posted by Mcfisty
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Part of the reason that they have opted for "Prescription Only" is because the 510(k) regulatory pathway requires the manufacturer to show substantial equivalence with respect to a predicate device. It is most likely that the closest device on the market for a successful 510(k) would be Drowzle, which itself is a prescription device. Hence they have to initially target the same user population and indications for use as Drowzle.
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Agree. Sleepcheck is a 'commercial failure" and it has been in 36 countries and still hasn't made any real money. Put sleepytown to rest and concentrate on the main game.
