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510(k) Data Aggregation
K Number
K012619Device Name
VT-1
Manufacturer
Date Cleared
2001-11-09
(88 days)
Product Code
Regulation Number
876.5020Why did this record match?
Applicant Name (Manufacturer) :
V.T.S.,INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the device is to assist users in achieving a full erection, i.e., to create an erection in men with Erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.
Device Description
VT-1 Vacuum Erection Device
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K Number
K012620Device Name
SE-200
Manufacturer
Date Cleared
2001-11-09
(88 days)
Product Code
Regulation Number
876.5020Why did this record match?
Applicant Name (Manufacturer) :
V.T.S.,INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the device is to assist users in achieving a full erection, i.e., to create an erection in men with Erectlle dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.
Device Description
Not Found
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K Number
K992442Device Name
V.T.S., INC. (V.T.-3)
Manufacturer
Date Cleared
1999-10-05
(75 days)
Product Code
Regulation Number
876.5020Why did this record match?
Applicant Name (Manufacturer) :
V.T.S.,INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the device is to assist users in achieving a full erection, i.e., to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.
Device Description
Not Found
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