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510(k) Data Aggregation
K Number
K041573Device Name
NANMA VACUUM PUMP PROXZEK MODEL 2M9498S
Manufacturer
NANMA MFG CO., LTD.
Date Cleared
2004-08-25
(72 days)
Product Code
LKY
Regulation Number
876.5020Why did this record match?
Product Code :
LKY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nanma Vacuum Pump is an external penile rigidity device designed to promote sufficient penile rigidity for sexual intercourse. The vacuum pump is used to create erections in men with erectile dysfunction. This device is intended for over-the-counter use (OTC)
Device Description
Not Found
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K Number
K032776Device Name
VACURECT VACUUM CONSTRICTION DEVICE
Manufacturer
VACURECT MANUFACTURING (PTY) LTD.
Date Cleared
2003-10-03
(25 days)
Product Code
LKY
Regulation Number
876.5020Why did this record match?
Product Code :
LKY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vacurect vacuum component is intended to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis. The constriction ring is intended to maintain penile rigidity in men with erectile dysfunction.
Device Description
The Vacurect Vacuum Constriction Device is an over the counter device that consists of two main components: the vacuum tube and the constriction ring. The vacuum tube consists of the pump sleeve, spacer ring, dome/sleeve O-Rings, dome/valve stopper, and vacuum ring. The Vacurect Vacuum Constriction Device works by creating a vacuum in the vacuum tube. This is accomplished by moving the pump sleeve up and down along the vacuum tube. The flexible rubber constriction ring when placed onto the vacuum tube (open end), forms an airtight seal with the vacuum tube. Once the opening of the constriction ring is placed on the penis head, the vacuum chamber is sealed and operation of the pump sleeve will immediately draw the penis into the vacuum tube. Once the required penis rigidity is reached. the vacuum pump mav be removed and the ring can remain on the penis for up to 30 minutes.
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K Number
K030119Device Name
NANMA ADJUSTABLE CONSTRICTION RING
Manufacturer
NANMA MFG CO., LTD.
Date Cleared
2003-08-06
(205 days)
Product Code
LKY
Regulation Number
876.5020Why did this record match?
Product Code :
LKY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nanma adjustable constriction rings are external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence. The Nanma adjustable constriction ring can be used alone or with a vacuum pump. This device is intended for over-the-counter use (OTC)
Device Description
Not Found
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K Number
K030913Device Name
NANMA VACUUM PUMP
Manufacturer
NANMA MFG CO., LTD.
Date Cleared
2003-06-03
(71 days)
Product Code
LKY
Regulation Number
876.5020Why did this record match?
Product Code :
LKY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nanma Vacuum Pumps are external penile rigidity devices designed to promote sufficient penile rigidity for sexual intercourse. The vacuum pumps are used to create erections in men with erectile dysfunction. This device is intended for over-the-counter use (OTC)
Device Description
Nanma Vacuum Pump, Model 2M1333
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K Number
K013113Device Name
MODIFICATION TO NANMA VACUUM PUMP
Manufacturer
NANMA MFG CO., LTD.
Date Cleared
2002-12-20
(458 days)
Product Code
LKY
Regulation Number
876.5020Why did this record match?
Product Code :
LKY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nanma Vacuum Pumps are external penile rigidity devices designed to promote sufficient penile rigidity for sexual intercourse. The vacuum pumps are used to create erections in men with erectile dysfunction. This device is intended for over-the-counter use (OTC)
Device Description
Nanma Vacuum Pumps Models 2M995, 2M438 .M330/3R. and 2M265
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K Number
K013051Device Name
NANMA ADJUSTABLE CONSTRICTION RING
Manufacturer
NANMA MFG CO., LTD.
Date Cleared
2002-08-22
(345 days)
Product Code
LKY
Regulation Number
876.5020Why did this record match?
Product Code :
LKY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nanma constriction rings (adjustable and stretchable) are external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence. The Nanma constriction ring can be used alone or with a vacuum pump. This device is intended for over-the-counter use (OTC)
Device Description
Nanma Adjustable and Stretchable Constriction Rings
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K Number
K020969Device Name
VACURECT VACUUM CONSTRICTION DEVICE
Manufacturer
VACURECT MANUFACTURING (PTY) LTD.
Date Cleared
2002-06-05
(71 days)
Product Code
LKY
Regulation Number
876.5020Why did this record match?
Product Code :
LKY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vacurect vacuum component is intended to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis. The constriction ring is intended to maintain penile rigidity in men with erectile dysfunction. The Vacurect Vacuum Constriction Device is intended for over-the-counter use.
Device Description
The Vacurect Vacuum Constriction Device is an over the counter device that consists of two main components: the vacuum tube and the constriction ring. The vacuum tube consists of the pump sleeve, spacer ring, dome/sleeve O-Rings, dome/valve stopper, and vacuum ring. The Vacurect Vacuum Constriction Device works by creating a vacuum in the vacuum tube. This is accomplished by moving the pump sleeve up and down along the vacuum tube. The flexible rubber constriction ring when placed onto the vacuum tube (open end), forms an airtight seal with the vacuum tube. Once the opening of the constriction ring is placed on the penis head, the vacuum chamber is sealed and operation of the pump sleeve will immediately draw the penis into the vacuum tube. Once the required penis rigidity is reached, the vacuum pump may be removed and the ring can remain on the penis for up to 30 minutes.
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K Number
K013053Device Name
MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING
Manufacturer
NANMA MFG CO., LTD.
Date Cleared
2002-05-09
(240 days)
Product Code
LKY
Regulation Number
876.5020Why did this record match?
Product Code :
LKY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nanma non-adjustable constriction rings are external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence. This device is intended for over-the-counter use (OTC)
Device Description
Nanma Adjustable constriction ring
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K Number
K020154Device Name
VT-1
Manufacturer
POS-T-VAC, INC.
Date Cleared
2002-04-04
(77 days)
Product Code
LKY
Regulation Number
876.5020Why did this record match?
Product Code :
LKY
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
K020258Device Name
SUPPORT SLEEVE
Manufacturer
POS-T-VAC, INC.
Date Cleared
2002-04-04
(69 days)
Product Code
LKY
Regulation Number
876.5020Why did this record match?
Product Code :
LKY
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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