A non-sterile, reusable vacuum therapy impotence management system.

A non
Rapport - Vacuum Therapy Device - SM 2000

A device that is applied externally to the penis for the management of erectile dysfunction (ED) (commonly known as impotence) to achieve selective penile tumescence and rigidity adequate for vaginal intercourse. It is typically a two-component device consisting of: 1) a manually-operated, vacuum pump/sleeve which is applied over the flaccid penis and used to create a vacuum to achieve tumescence through an up and down movement along a vacuum tube; and 2) a constriction ring used in conjunction with the pump and placed upon the penis to maintain the erection. The ring remains on the penis for a recommended period of time. This is a reusable device.

• Width: 67 Millimeter
• Length: 220 Millimeter

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LKY

Device Name: Device, External Penile Rigidity

Device Class: 2

Physical State: N/A

Definition: Intended to create or maintain sufficient penile rigidity for sexual intercourse. These include vacuum pumps, constriction rings, and penile splints, which are mechanical, powered or pneumatic devices.

Submission Type ID: 4

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 876.5020

Third Party Flag: N

Medical Specialty: GU

Device Id: 00384702000019

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 00384702000033

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00384702000019

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case