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Found 11 results

510(k) Data Aggregation

    K Number
    K020154
    Device Name
    VT-1
    Manufacturer
    POS-T-VAC, INC.
    Date Cleared
    2002-04-04

    (77 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    POS-T-VAC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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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    K Number
    K020258
    Device Name
    SUPPORT SLEEVE
    Manufacturer
    POS-T-VAC, INC.
    Date Cleared
    2002-04-04

    (69 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    POS-T-VAC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the device is to assist users by supporting the penis during intimacy. Used by men with the inability to achieve vaginal penetration, due to a flaccid or partially erect penis.
    Device Description
    Support Sleeve
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    K Number
    K012670
    Device Name
    BOSS 2000-3 VACUUM ERECTION DEVICE
    Manufacturer
    POS-T-VAC, INC.
    Date Cleared
    2001-11-09

    (88 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    POS-T-VAC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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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    K Number
    K012672
    Device Name
    BOSS-2000-2 VACUUM ERECTION DEVICE
    Manufacturer
    POS-T-VAC, INC.
    Date Cleared
    2001-11-09

    (88 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    POS-T-VAC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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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    K Number
    K983245
    Device Name
    POS-T-VAC (AVP-1000)
    Manufacturer
    POS-T-VAC, INC.
    Date Cleared
    1998-11-02

    (47 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    POS-T-VAC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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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    K Number
    K983246
    Device Name
    POS-T-VAC (IVP-600)
    Manufacturer
    POS-T-VAC, INC.
    Date Cleared
    1998-11-02

    (47 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    POS-T-VAC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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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    K Number
    K981011
    Device Name
    POS-T-VAC (REJOYN VACUUM ERECTION DEVICE)
    Manufacturer
    POS-T-VAC, INC.
    Date Cleared
    1998-08-28

    (163 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    POS-T-VAC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Rejoyn Vacuum Erection 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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    K Number
    K981180
    Device Name
    REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING KIT AND POS-T-VAC B-10 RING KIT
    Manufacturer
    POS-T-VAC, INC.
    Date Cleared
    1998-08-28

    (149 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    POS-T-VAC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    All four sets of constriction rings, the Rejoyn Constriction Ring Kit, B-100, B-25, and B-10, are used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection (either with the aid of a vacuum pump, or naturally). The constriction band is 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
    K961309
    Device Name
    POS-T-VAC ID-300
    Manufacturer
    POS-T-VAC, INC.
    Date Cleared
    1996-06-10

    (67 days)

    Product Code
    KZH
    Regulation Number
    880.6920
    Why did this record match?
    Applicant Name (Manufacturer) :

    POS-T-VAC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K960828
    Device Name
    POS-T-VAC B-10 BAND KIT
    Manufacturer
    POS-T-VAC, INC.
    Date Cleared
    1996-03-08

    (8 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    POS-T-VAC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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