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510(k) Data Aggregation
K Number
K980567Device Name
CHARGER (ED)
Manufacturer
Date Cleared
1998-05-06
(82 days)
Product Code
Regulation Number
876.5020Why did this record match?
Applicant Name (Manufacturer) :
WALLING MEDICAL EQUIPMENT CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Charger is used to cause engorgement of the penis for men that are having difficulty with organic or psychological impotence.
Device Description
The Charger is used by impotent men to allow them to resume having sexual intercourse. It consists of a clear polycarbonate cylinder used as a vacuum chamber, that fits over the penis, and a vacuum pump with vacuum release trigger to evacuate air from the cylinder. As the air is removed from the chamber the negative pressure allows blood engorgement of the penis. When a sufficient erection occurs for vaginal penetration a Reliant constriction ring (K980567) is slipped over the base of the penis to act as a partial tourniquet retaining the erection. The ring may be worn for a maximum of thirty minutes before it MUST be removed. The kit comes with a set of 4 ring sizes. The pumps' ability to create a vacuum is limited by an automatic vacuum release valve so it cannot exceed the known safe limit of 17 in. Hg. The rings are elastic pharmaceutical quality material. The ring safety removal loops were performance tested for strength.
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K Number
K980752Device Name
XTEND
Manufacturer
Date Cleared
1998-05-06
(75 days)
Product Code
Regulation Number
876.5020Why did this record match?
Applicant Name (Manufacturer) :
WALLING MEDICAL EQUIPMENT CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Xtend ring is used to maintain engorgement of the penis for men that are having difficulty with organic or psychological erectile dysfunction.
Device Description
The Xtend rings are used by men with erectile dysfunction to improve their ability to have sexual intercourse. When they have a sufficient erection for intercourse a Xtend constriction ring (K980752) is slipped over the base of the penis to act as a partial tourniquet retaining the erection. The ring may be worn for a maximum of thirty minutes before it MUST be removed. The Xtend ring kit consists of a set of 4 rings. The rings are elastic pharmaceutical quality material which come with an applicator and ring removal hooks. The ring safety removal loops were performance tested for strength. All warnings and precautions from the FDA internet address, www.fda.gov/cdch/ode/oxponrig.html, are included in the premarket notification.
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K Number
K971768Device Name
RELIANT CHARGER
Manufacturer
Date Cleared
1997-09-29
(139 days)
Product Code
Regulation Number
876.5020Why did this record match?
Applicant Name (Manufacturer) :
WALLING MEDICAL EQUIPMENT CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Reliant Charger is used to cause engorgement of the penis for men that are having difficulty with organic or psychological impotence.
Device Description
Not Found
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