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510(k) Data Aggregation
K Number
K020808Device Name
FERTILITE OV
Manufacturer
PHEROMONE SCIENCES CORP.
Date Cleared
2002-09-23
(195 days)
Product Code
NGE
Regulation Number
862.1485Why did this record match?
Applicant Name (Manufacturer) :
PHEROMONE SCIENCES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fertilité OV™ (PSC Fertility Monitor) is an over-the-counter ("OTC") in vitro diagnostic ("IVD") device intended for use by women as an aid in conception by measuring hormone-induced changes in the composition of the perspiration on the skin during the menstrual cycle. Properly used, it gives more notice for conceiving and is not invasive. It is NOT to be used for contraception.
Device Description
The PSC Fertility Monitor consists of a small wristwatch that houses an interactive microprocessor and a biochemical sensor. The device measures chloride ion levels in female sweat from the skin surface in order to predict current fertility status by displaying the result on the screen. The device provides the user with notice up to four days before ovulation during which the user may have the greatest chance of becoming pregnant.
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