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510(k) Data Aggregation

    K Number
    K993142
    Device Name
    ELITE CUSTOM
    Manufacturer
    SOMA BLUE, INC.
    Date Cleared
    1999-12-27

    (97 days)

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

    SOMA BLUE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Elite Custom consists of a manual vacuum pump, a cylinder, cushion inserts, constriction ring loader, constriction rings, and lubricant. The Elite Custom's intended use is to manage erectile dysfunction by allowing the creation of a full erection suitable for sexual activity. This is accomplished through the use of the manual vacuum pump to remove air from the cylinder, creating vacuum pressure within the cylinder. Blood is thereby drawn into the penis, causing it to become erect. The constriction ring is then placed around the base of the erect penis to restrict the outflow of blood. When activity is complete, the ring is removed from the base of the + penis. This product is intended for prescription use.
    Device Description
    The Elite Custom consists of a manual vacuum pump, a cylinder, cushion inserts, constriction ring loader, constriction rings, and lubricant.
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    K Number
    K993143
    Device Name
    VITALITY SYSTEM
    Manufacturer
    SOMA BLUE, INC.
    Date Cleared
    1999-12-27

    (97 days)

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

    SOMA BLUE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vitality System consists of a manual vacuum pump, a cylinder, cushion inserts, constriction ring loader, constriction rings, and lubricant. The Vitality System's intended use is to manage erectile dysfunction by allowing the creation of a full erection suitable for sexual activity. This is accomplished through the use of the manual vacuum pump to remove air from the cylinder, creating vacuum pressure within the cylinder. Blood is thereby drawn into the penis, causing it to become erect. The constriction ring is then placed around the base of the erect penis to restrict the outflow of blood. When activity is complete, the ring is removed from the base of the penis. This product is intended for over the counter use.
    Device Description
    The Vitality System consists of a manual vacuum pump, a cylinder, cushion inserts, constriction ring loader, constriction rings, and lubricant.
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