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510(k) Data Aggregation
K Number
K080200Device Name
WATER WORKS DOUCHING DEVICE
Manufacturer
Date Cleared
2008-07-10
(167 days)
Product Code
Regulation Number
884.5900Why did this record match?
Product Code :
HED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The WaterWorks® Douching Device is indicated for the reduction or abatement of perceived vaginal odor with or without complaints of discharge in women with no infectious cause of vaginitis.
Device Description
The Water Works® Douching Device is a reusable system consisting of a customized 32 ounce, water container, connecting hose and a stainless steel nozzle. A hose clamp for controlling water flow through the hose and a plastic loop to attach the container to a shower head are also provided. The container is filled with tepid tap water which flows through the hose to the nozzle. The water container is hung approximately 3 feet above the vagina (eye-level).
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K Number
K030056Device Name
WORRY-REMOVER IRRIGATOR
Manufacturer
Date Cleared
2003-04-22
(106 days)
Product Code
Regulation Number
884.5900Why did this record match?
Product Code :
HED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The WORRRY-REMOVER™ IRRIGATOR is designed for use as a vaginal douche apparatus for general feminine hygiene applications.
Device Description
The irrigating-bottle is hand-squeezed to force the cleaning solution to slowly and completely flow into the vaginal cavity. The one-way liquid valve permits the fluid to flow only from the bottle into the vaginal cavity but not back to the bottle, preventing contaminations of the solution and bottle. The one-way air valve permits air to flow into the bottle to prevent production of negative pressure within the bottle. The flow speed of the liquid is controlled by the user's hand. This system makes the process of vaginal irrigation much easier, neater, and more relaxing than using some other types of irrigators.
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K Number
K000736Device Name
LA JOIE
Manufacturer
Date Cleared
2000-08-08
(154 days)
Product Code
Regulation Number
884.5900Why did this record match?
Product Code :
HED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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