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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?
Product Code :
NGE
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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K Number
K990223Device Name
MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR
Manufacturer
UNIPATH LTD.
Date Cleared
1999-02-24
(30 days)
Product Code
NGE, CEP, LHD
Regulation Number
862.1485Why did this record match?
Product Code :
NGE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CLEARPLAN EASY FERTILITY MONITOR, an over-the-counter (OTC) in vitro diagnostic device, is intended to be used by women as an aid in the timing of intercourse by identifying those days in a woman's cycle on which intercourse is most likely to lead to conception via a urine test. The device consists of a software-controlled electronic monitor and urine test sticks. The consumer purchases this product through pharmacies and drug stores.
The CLEARPLAN DATA TRANSFER SYSTEM is an accessory to the CLEARPLAN EASY FERTILITY MONITOR which allows the information collected by this product to be transferred to and stored on a computer, and viewed on the computer display or printed out. The CLEARPLAN DATA TRANSFER SYSTEM also allows the time of access of the data to be recorded electronically and the data to be collated on the computer.
The target market for the CLEARPLAN DATA TRANSFER SYSTEM is women who have purchased the CLEARPLAN EASY FERTILITY MONITOR. The device will be of use to Obstetricians, Gynaecologists and Fertility Specialists.
The CLEARPLAN DATA TRANSFER SYSTEM is intended to transfer data which have already been collected by the user of the CLEARPLAN EASY FERTILITY MONITOR. The information which is presented to the user of the device is analogous to that which they could have recorded on paper on a daily basis by noting the indications given by the MONITOR. It does not affect the interpretation of the results of the user's own activities. Therefore the CLEARPLAN DATA TRANSFER SYSTEM does not affect the scientific technology of the CLEARPLAN EASY FERTILITY MONITOR.
Device Description
The CLEARPLAN EASY FERTILITY MONITOR, an over-the-counter (OTC) in vitro diagnostic device, is intended to be used by women as an aid in the timing of intercourse by identifying those days in a woman's cycle on which intercourse is most likely to lead to conception via a urine test. The device consists of a software-controlled electronic monitor and urine test sticks.
The CLEARPLAN DATA TRANSFER SYSTEM is an accessory to the CLEARPLAN EASY FERTILITY MONITOR which allows the information collected by this product to be transferred to and stored on a computer, and viewed on the computer display or printed out. The CLEARPLAN DATA TRANSFER SYSTEM also allows the time of access of the data to be recorded electronically and the data to be collated on the computer. The CLEARPLAN DATA TRANSFER SYSTEM consists of a software controlled electronic card reader, a connecting cable, electronic memory cards and user instructions.
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K Number
K981207Device Name
CLEARPLAN EASY FERTILITY MONITOR
Manufacturer
UNIPATH LTD.
Date Cleared
1998-10-28
(209 days)
Product Code
NGE, CEP, LHD
Regulation Number
862.1485Why did this record match?
Product Code :
NGE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CLEARPLAN EASY FERTILITY MONITOR is an interactive system which is designed to identify those days in a woman's cycle on which intercourse is most likely to lead to conception. Women are instructed to act on this information to achieve a pregnancy.
The target market for the CLEARPLAN EASY FERTILITY MONITOR is women who are either planning a pregnancy, or who have been trying for a pregnancy for a number of months without success. In addition, the device will be of use to Obstetricians, Gynaecologists and Fertility Specialists.
The device will provide warning of impending ovulation through detection of the luteinising hormone (LH) surge which precedes it. Besides this feature, CLEARPLAN EASY FERTILITY MONITOR will provide additional warning of ovulation through detection of a rise in the level of estrone-3-glucuronide (E3G) in urine. The product will define three phases of fertility through early morning urine hormone measurement: low, high and peak fertility.
CLEARPLAN EASY FERTILITY MONITOR is designed to adapt its testing strategy to the individual.
CLEARPLAN FERTILITY EASY MONITOR will be labelled not for contraceptive use.
Device Description
The CLEARPLAN EASY FERTILITY MONITOR is an interactive system which is designed to identify those days in a woman's cycle on which intercourse is most likely to lead to conception. The device will provide warning of impending ovulation through detection of the luteinising hormone (LH) surge which precedes it. Besides this feature, CLEARPLAN EASY FERTILITY MONITOR will provide additional warning of ovulation through detection of a rise in the level of estrone-3-glucuronide (E3G) in urine. The product will define three phases of fertility through early morning urine hormone measurement: low, high and peak fertility. CLEARPLAN EASY FERTILITY MONITOR is designed to adapt its testing strategy to the individual.
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K Number
K973860Device Name
OVULON MONITOR
Manufacturer
CONCEPTION TECHNOLOGY, INC.
Date Cleared
1998-01-07
(90 days)
Product Code
NGE
Regulation Number
862.1485Why did this record match?
Product Code :
NGE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ovulon Monitor is a fertility aid intended for over-the-counter purchase. It is an electronic biosensor designed for home use that vields digital information (data points) relative to electron flow in the extracellular milieu of the posterior fornix and paracervical region of the vagina.
The Ovulon Monitor is intended for daily use in normally cycling (i.e., regularly menstruating and, presumably, ovulating) healthy females who may desire to achieve pregnancy (conception). Much as a basal body temperature thermometer or a home urine LH kit, the Ovulon Monitor serves as an independent information aid to the woman by helping to define the fertile window near the midpoint of each monthly cycle, whereby she may choose the proper timing for vaginal intercourse. If the user chooses the guidance of a physician for fertility treatment, the Ovulon Monitor may serve to provide the user and her physician with data to better time artificial insemination or other interventional techniques.
The Ovulon Monitor is to be used as an aid to conception and is not to be used for contraception.
After six (6) or more cycles, if the user is not successful in achieving conception, she should consult her physician.
Device Description
The Ovulon Monitor is an electronic biosensor designed for home use that vields digital information (data points) relative to electron flow in the extracellular milieu of the posterior fornix and paracervical region of the vagina.
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