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510(k) Data Aggregation

    K Number
    K012619
    Device Name
    VT-1
    Manufacturer
    Date Cleared
    2001-11-09

    (88 days)

    Product Code
    Regulation Number
    876.5020
    Why 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
    K012620
    Device Name
    SE-200
    Manufacturer
    Date Cleared
    2001-11-09

    (88 days)

    Product Code
    Regulation Number
    876.5020
    Why 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
    K992442
    Device Name
    V.T.S., INC. (V.T.-3)
    Manufacturer
    Date Cleared
    1999-10-05

    (75 days)

    Product Code
    Regulation Number
    876.5020
    Why 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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    Ask a specific question about this device

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