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Found 6 results
510(k) Data Aggregation
K Number
K002329Device Name
PELVX GELLHORN VAGINAL PESSARY 603-608
Manufacturer
DESCHUTES MEDICAL PRODUCTS, INC.
Date Cleared
2000-09-18
(48 days)
Product Code
HHW
Regulation Number
884.3575Why did this record match?
Applicant Name (Manufacturer) :
DESCHUTES MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994079Device Name
REFLEX TREATMENT SYSTEM
Manufacturer
DESCHUTES MEDICAL PRODUCTS, INC.
Date Cleared
2000-03-01
(90 days)
Product Code
HIR, 85H
Regulation Number
884.1425Why did this record match?
Applicant Name (Manufacturer) :
DESCHUTES MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ReFlex Treatment System is intended for the treatment of stress incontinence and/or urge incontinence in females.
Device Description
The ReFlex Treatment System is a comprehensive, behavioraliy-based program designed for independent use by incontinent people in their own home. The product kit includes a personal training device, an informational video, instructional journal, and direct clinical support via phone and internet. At the program's core is the pneumatically-based ReFlex Trainer, a handheld device which when connected to the vaginal sensor displays the magnitude of pelvic muscle contractions.
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K Number
K990593Device Name
PELVX INCONTINENCE DISH, MODEL 301-306
Manufacturer
DESCHUTES MEDICAL PRODUCTS, INC.
Date Cleared
1999-05-24
(89 days)
Product Code
HHW, 85H
Regulation Number
884.3575Why did this record match?
Applicant Name (Manufacturer) :
DESCHUTES MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PelvX Incontinence Dish Vaginal Pessary is intended for treatment of stress urinary incontinence combined with a mild 1st or 2nd degree uterine prolapse and/or a mild cystocele.
Device Description
The PelvX Incontinence Dish Vaginal Pessary is a pessary intended for the treatment of stress urinary incontinence. It is made of medical grade silicone and is shaped like a dish to surround and support the cervical area and bladder areas. Holes in the dish allow drainage of vaginal fluids. It features a bulbous portion at one location on its circumference designed to support and elevate the bladder neck, thereby providing improved urethral sphincter control.
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K Number
K974115Device Name
PELVX RING, PELVX RING WITH SUPPORT
Manufacturer
DESCHUTES MEDICAL PRODUCTS, INC.
Date Cleared
1998-04-27
(178 days)
Product Code
HHW
Regulation Number
884.3575Why did this record match?
Applicant Name (Manufacturer) :
DESCHUTES MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PelvX Ring Vaginal Pessary is a vaginal pessary intended for support of 1st and 2nd degree prolapse.
The PelvX Ring with Support Vaginal Pessary is a vaginal pessary intended for support of 1st and 2nd degree prolapse combined with mild cystocele.
Device Description
Not Found
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K Number
K974116Device Name
PELVX INCONTINENCE RING
Manufacturer
DESCHUTES MEDICAL PRODUCTS, INC.
Date Cleared
1998-04-27
(178 days)
Product Code
HHW
Regulation Number
884.3575Why did this record match?
Applicant Name (Manufacturer) :
DESCHUTES MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PelvX Incontinence Ring Vaginal Pessary is a vaginal pessary intended for treatment of of a sourinary incontinence.
Device Description
PelvX Incontinence Ring Vaginal Pessary
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K Number
K974117Device Name
PELVX DONUT, PELVX CUBE
Manufacturer
DESCHUTES MEDICAL PRODUCTS, INC.
Date Cleared
1998-04-27
(178 days)
Product Code
HHW
Regulation Number
884.3575Why did this record match?
Applicant Name (Manufacturer) :
DESCHUTES MEDICAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PelvX Donut Vaginal Pessary is a vaginal pessary intended for support of 310 degree prolapse.
The PelvX Cube Vaginal Pessary is a vaginal pessary intended for support of 314 degree prolapse combined with rectocele and/or cystocele.
Device Description
Not Found
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