Search Results
Found 2 results
510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
VACURECT MANUFACTURING (PTY) LTD.
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.
Ask a Question
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?
Applicant Name (Manufacturer) :
VACURECT MANUFACTURING (PTY) LTD.
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.
Ask a Question
Page 1 of 1