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Simpsonly

05/14/18 7:50 AM

#137100 RE: Daytime_Lantern #137089

This may seem like a foolish question, but perhaps srin or sausage, or someone else, may be able to clarify?

If BIEL receives FDA clearance for musculoskeletal pain, why would it still be necessary to go through a separate regulatory clearance process for Allay as a medical device for the treatment of Dysmenorrhea, when it is a malady involving severe cramping of muscles and the resulting pain? Seems to me that marketing the device as ‘ActiPatch Allay’ or ‘Allay by ActiPatch’ hits the mark?

BIEL ActiPatch Allay....Tsunami....imminently