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Found 4 results
510(k) Data Aggregation
K Number
K993721Device Name
UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES
Manufacturer
LABORIE MEDICAL TECH CORP.
Date Cleared
1999-11-29
(26 days)
Product Code
KPI
Regulation Number
876.5320Why did this record match?
Applicant Name (Manufacturer) :
LABORIE MEDICAL TECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UROSTYM™ Biofeedback and Stimulation Device Anal/Rectal Probes are used in treating urinary incontinence by way of perineal reeducation and stimulation. This device is a non-implanted electrical stimulator applied the pelvic floor musculature and surrounding structures for therapy in the treatment of urinary incontinence. These probes are provided non-sterile for single patient use/disposable. The probes are for office use under the direction of a physician or licensed health care professional.
Device Description
The UROSTYM™ Biofeedback and Stimulation Device Anal/Rectal Probes are non-implanted electrical stimulators applied the pelvic floor musculature and surrounding structures for therapy in the treatment of urinary incontinence. These probes are provided non-sterile for single patient use/disposable.
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K Number
K990041Device Name
UROSTYM BIOFEEDBACK AND STIMULATION PROBES
Manufacturer
LABORIE MEDICAL TECH CORP.
Date Cleared
1999-08-05
(211 days)
Product Code
KPI
Regulation Number
876.5320Why did this record match?
Applicant Name (Manufacturer) :
LABORIE MEDICAL TECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UROSTYM™ Biofeedback and Stimulation Probes are indicated for use in Treating urinary incontinence by way of re-education and stimulation. The UROSTYM non-implanted electrical Stimulation applied to the pelvic floor musculature and surrounding Pelvic Structures for therapy in the Treatment of urinary Incontinence. The probes are provided for single patient use/disposable. The non-steril probes are for office use under the direction of a physican or licensed health care professional.
Device Description
UROSTYM™ Biofeedback and Stimulation Device - Vaginal Probe Models 3AT2B and TP2B
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K Number
K991479Device Name
VISER PENILE TUMESCENCE MONITOR
Manufacturer
LABORIE MEDICAL TECH CORP.
Date Cleared
1999-07-07
(70 days)
Product Code
LIL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LABORIE MEDICAL TECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VISER™ penile tumescence monitor is a noninvasive monitoring device used to measure intracavernosal pressure (ICP) and blood flow in the penis. This monitoring assists the physician in the diagnosis of erectile dysfunction. VISERTM is a prescriptive device to be used under the direction of a physician or other authorized health care professional.
Device Description
Not Found
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K Number
K963064Device Name
ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM
Manufacturer
LABORIE MEDICAL TECH CORP.
Date Cleared
1997-06-05
(302 days)
Product Code
FFX
Regulation Number
876.1725Why did this record match?
Applicant Name (Manufacturer) :
LABORIE MEDICAL TECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ano-Rectal Manometry (ARM) Option to Laborie's PC-based urodynamic systems is intended to be used in quantifying ano-rectal pressures. Using the same transducers as for urodynamics but with a different measuring range, the ARM Option can be used for performing standard ano-rectal manometric measurements.
Device Description
Ano-rectal Manometry Option Device, Model UDS-ARM
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