The Conception Kit® Offers Couples Reliability and Peace of Mind with FDA Clearance

The Conception Kit® at-home system is an FDA-cleared fertility treatment that can be safely and easily used in the privacy of home. There is a prescription fertility treatment that is FDA-cleared to treat common infertility issues including low sperm count, low sperm motility, and an acidic vaginal pH environment. It is designed around the proven methodology of cervical cap insemination that has been used by doctors to effectively treat infertility for over fifty years. Under the 510K FDA classification, the Conception Kit® at-home system is able to claim the class of cervical caps which historically achieve pregnancy rates up to 44%. This is great news for couples who are looking for a safe and effective infertility treatment that can be used at home. To earn the 510K clearance with the FDA, Conceivex Inc. had to demonstrate a variety of factors about the Conception Kit® at-home system including: That the Conception Cap®(cervical cap) is substantially equivalent to the predicate devices in terms of safety and effectiveness. That patients could use the Conception Kit® and Conception Cap® in the privacy of their home correctly (keep in mind that up to this time period all cervical caps for insemination were used in a physician [...]

By |2017-01-01T11:23:50+00:00May 18th, 2016|Conception Kit|Comments Off on The Conception Kit® Offers Couples Reliability and Peace of Mind with FDA Clearance
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