Replies to post #202002 on Bioelectronics Corp (BIEL)

[srinsocal]

Found it interesting Hawk that the Livia, which is TENS Tech, was cleared for Chronic Pain and General Muscle Pain with no mention of Menstrual Pain and yet they market it specifically as a Period Pain Product.

I thought reproductive pain relief would require more scrutiny. The 510k even says:

"Discussion of Clinical Tests Performed: Livia Inc. determined that bench and non clinical testing were sufficient to demonstrate that the LIVIA device is as safe and effective as the predicate devices."

The FDA is letting the applicant determine what type of testing is needed, especially on a Menstrual Pain product???

https://www.accessdata.fda.gov/cdrh_docs/pdf16/K163153.pdf