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510(k) Data Aggregation
K Number
K974082Device Name
THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE
Manufacturer
Date Cleared
1998-02-27
(121 days)
Product Code
Regulation Number
876.5020Why did this record match?
Applicant Name (Manufacturer) :
PERFORMANCE PLUS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Performance Plus Confidence Rings are devices that are placed around the base of the penis to help sustain an erection. An erection is achieved when the spongy corpora of the penis fills with arterial blood during sexual stimulation. In certain men, the penis may not become fully erect because the penile venous system drains too rapidly or leaks blood from the corpora. The rings operate by limiting venous return from the major superficial veins of the penis.
The E.I.D. system is an external erection device that induces penile rigidity though vacuum assisted vascular engorgement of the penis. Once erection is achieved, a Confidence ring is placed at the base of the penis to sustain the erection.
Device Description
The Performance Plus Confidence rings are soft, pliable rings with a tab for removal. The E.I.D. system consists of a vacuum tumescence pump, a vacuum chamber with inserts, Confidence rings, lubricating gel, instructions for use, and a carrying case.
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