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510(k) Data Aggregation

    K Number
    K990006
    Device Name
    ERCO-VAC -C
    Manufacturer
    Date Cleared
    1999-02-24

    (51 days)

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

    ERCONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Erco-Vac ™ -C is used to create an erection in men with erectile dysfunction and for augmenting of male potency. Erco-Vac TM -C can be used for patients with following conditions: Diabetes Venous leakage Prostatectomy Hypertension Psychogenic condition Impotence due to radiation therapy Spinal cord injury
    Device Description
    Erco-Vac ™ -C is based on the same scientific concept as known marketable vacuum constriction devices. Vacuum applied to penis causes blood inflow, engorgement and state of erection. Constriction device preliminary installed on the edge of vacuum chamber is forced to slip off on the root of the penis. By hindering blood outflow, constriction device sustains erection and makes intercourse possible after removal of vacuum chamber.
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    K Number
    K990008
    Device Name
    ERCO-RIBBON -C
    Manufacturer
    Date Cleared
    1999-02-24

    (51 days)

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

    ERCONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Erco-Ribbon ™ - C is used to maintain penile rigidity in men with erectile dysfunction. It restricts blood outflow from the penis after the patient has obtained an erection (either with the aid of a vacuum pump, or naturally). Men with firm but short lasting erection may use constricting device separately. If a man is impotent to a degree that he is unable to achieve a natural erection, a vacuum constriction system may help him to overcome this dysfunction. Erco-Ribbon ™ - C can be used for patients with following conditions: - a) separately: premature ejaculation, firm but short lasting erection. b) as a part of a vacuum constriction system: Diabetes Venous leakage Prostatectomy Hypertension Psychogenic impotence Impotence due to radiation therapy Spinal cord injury
    Device Description
    Erco-Ribbon ™-C is an improved version of Erco-Ribbon ™, using a cuff for forming a shell around the ribbon and a quick release loop for removing the constrictor. A constriction ribbon is made of elastic and soft rubber-like material with generally rectangular cross section. For arrangement of Erco-Ribbon ™-C penile constriction device, the ribbon is wrapped with the tension by multyple turns over the proximal end of the mounting tube (or a vacuum chamber, when Erco-Ribbon ™-C is used as a part of a vacuum constriction system). Erco-Ribbon ™-C is locked by the cuff in a state with prearranged inward pressure. A quick release loop unlocks the constrictor and allows easy removal of the ribbon. The materials conform FDA regulation for devices contacting human skin. A mounting tube is made of a segment of acrylic tube.
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    K Number
    K981343
    Device Name
    ERCO-RIBBON
    Manufacturer
    Date Cleared
    1998-11-24

    (225 days)

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

    ERCONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Erco-Ribbon ™ is used to maintain penile rigidity in men with erectile dysfunction. It restricts blood outflow from the penis after the patient has obtained an erection (either with the aid of a vacuum pump, or naturally). Men with firm but short lasting erection may use constricting device separately. If a man is impotent to a degree that he is unable to achieve a natural erection, a vacuum constriction system may help him to overcome this dysfunction. Erco-Ribbon ™ can be used for patients with following conditions: - a) separately: premature ejaculation, firm but short lasting erection. b) as a part of a vacuum constriction system: Diabetes Venous leakage Prostatectomy Hypertension Psychogenic impotence Impotence due to radiation therapy Spinal cord injury
    Device Description
    A constriction ribbon is made of elastic and soft rubber-like material with generally rectangular cross section. A belt with release loop is used for keeping the constrictor in a prearranged tightened position and for unlocking the ribbon. The material conforms FDA regulation for devices contacting human skin. For unlocking of the constrictor, the belt's release loop is pulled forward. The belt slips off, allowing easy unwrapping of the constricting ribbon. A mounting tube comprises a segment of acrylic tube.
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    K Number
    K981357
    Device Name
    ERCO-VAC
    Manufacturer
    Date Cleared
    1998-11-24

    (224 days)

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

    ERCONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Erco-Vac™ is used to create an erection in men with erectile dysfunction. Erco-Vac™ can be used for patients with following conditions: Diabetes, Venous leakage, Prostatectomy, Hypertension, Psychogenic impotence, Impotence due to radiation therapy, Spinal cord injury.
    Device Description
    Erco-Vac™ is based on the same scientific concept as known marketable vacuum constriction devices. Vacuum applied to penis causes blood inflow, engorgement and state of erection. Constriction device preliminary installed on the edge of vacuum chamber is forced to slip off on the root of the penis. By hindering blood outflow, constriction device sustains erection and makes intercourse possible. After releasing of vacuum and vacuum chamber removal, the user is ready to intercourse.
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    K Number
    K972537
    Device Name
    ERCO-VAC
    Manufacturer
    Date Cleared
    1997-11-03

    (118 days)

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

    ERCONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Erco-Vac™ is used to maintain penile rigidity in men with erectile dysfunction. Erco-Vact can be used for patients with following conditions: Diabetes Venous leakage Prostatectomy Hypertension Psychogenic condition Impotence due to radiation therapy Spinal cord injury
    Device Description
    Erco-Vac™ is based on the same scientific concept as known marketable vacuum constriction devices. Vacuum applied to penis causes blood inflow, engorgement and state of erection. Constriction device preliminary installed on the edge of vacuum chamber is forced to slip off on the root of the penis. By hindering blood outflow, constriction device sustains erection and makes intercourse possible. After releasing of vacuum and vacuum chamber removal, the user is ready to intercourse. Vacuum constriction treatment is now recognized as the first line remedy, preferable to other treatments of erection dysfunction - sex therapy, self injections, venous and arterial surgery, implantation of penile prosthesis. It is noninvasive, provides instant results and is applicable to almost all kinds of impotence as well as for augmenting male potency. At the same time, known marketable devices have deficiencies and drawbacks which make them unacceptable to many potential users. Erco-Vac™ was developed with the goal to overcome known deficiencies and limitations of vacuum constriction devices. Novelty elements, introduced into the system's structure are listed below: 1. Transferable air tight penile seal. 2. Constriction device with controllable inward radial pressure. 3. Automatic vacuum release. 4. Transferring device. 5. Vacuum chamber with a domed closed end
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    K Number
    K972353
    Device Name
    ERCO-RIBBON
    Manufacturer
    Date Cleared
    1997-10-28

    (126 days)

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

    ERCONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Erco-Ribbon™ is 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). Erco-Ribbon can be used for patients with following conditions: a) separately: premature ejaculation firm but short lasting erection b) as a part of a vacuum constriction system Diabetes Venous leakage Prostatectomy Hypertension Psychogenic condition Radiation therapy Spinal cord injury
    Device Description
    A constriction ribbon is made of elastic and soft silicone with generally rectangular cross section. A belt with release loop is used for keeping the constrictor in a prearranged tightened position and for unlocking the ribbon. The material conforms FDA regulation for devices contacting human skin. For unlocking of the constrictor. the belt's release loop is pulled forward. The belt slips off, allowing easy unwrapping of the constricting ribbon. A mounting tube comprises a segment of acrylic tube. For arrangement of Erco-Ribbon™ penile constriction device, the ribbon is wrapped with the tension by multyple turns over the segment of the proximal end of the mounting tube. (or a vacuum chamber, when Erco-Ribbon ™ is used as a part of a vacuum constriction system),
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