Monday, October 21, 2019 10:09:01 PM
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
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