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510(k) Data Aggregation
K Number
K131198Device Name
TIPI OTC
Manufacturer
CONTIPI LTD.
Date Cleared
2013-08-27
(123 days)
Product Code
HHW
Regulation Number
884.3575Why did this record match?
Applicant Name (Manufacturer) :
CONTIPI LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IMPROVE BLADDER SUPPORT is an over-the-counter device intended for the temporary management of stress urinary incontinence (SUI) in women.
Device Description
The IMPROVE BLADDER SUPPORT device is a single use vaginal pessary, inserted into the vagina, by the user herself, using an applicator similar to a menstrual tampon applicator. The device comprises of a flexible silicone rubber core, covered with a non-woven mesh, and a removal string. Once inserted into the vagina, the core and cover of the device provides tension free mid-urethral support for the temporary management of stress urinary incontinence (SUI). After a maximum of 8 hours of use in a 24 hours period, the device should be removed from the vagina using its pull string and discarded.
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K Number
K060526Device Name
TIPI
Manufacturer
CONTIPI LTD.
Date Cleared
2006-06-09
(102 days)
Product Code
HHW
Regulation Number
884.3575Why did this record match?
Applicant Name (Manufacturer) :
CONTIPI LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vaginal Pessary device is indicated for temporary management of genuine (mild, moderate, and severe) stress urinary incontinence in females.
Device Description
a device which is placed intra-vaginally to provide mid-urethral support. The soft, flexibie device is inserted via an applicator, looks like a tampon applicator, and once placed in the vagina, expands to provide mild tension on the vaginal walls. It is has flexible arms that continue to provide support during normal body movement. It is removed via a pull string, like a tampon. It is single use, disposable and may be worn up to 8 hours at a time. It is available in multiple sizes to accommodate differences in vaginal anatomy and severity of urine leakage.
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