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510(k) Data Aggregation
K Number
DEN130047Device Name
PROLONG
Manufacturer
Date Cleared
2015-03-20
(487 days)
Product Code
Regulation Number
876.5025Why did this record match?
Applicant Name (Manufacturer) :
ERGON MEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Prolong is used as part of a climax control program for males who suffer from premature ejaculation. It is designed to increase the time between arousal and ejaculation through the use of the training sessions using the stimulating vibratory effects of the device on the penis as part of the "start-stop" technique. Prolong is intended to be available as an over-the-counter device.
Device Description
The PROLONG™ device consists of the PROLONG™ vibrating device and a 4-ounce bottle of water-based lubricant. The lubricant was FDA cleared under K013086. The PROLONG™ vibrating device includes a white silicone body and a vibrator unit as shown in Figure 1. The vibrator unit comprises a 3-Volt coin (pancake) motor connected to a battery pack of two battery cells (Type PX625A) shrink wrapped together and an Acrylonitrile Butadiene Styrene (ABS) slide switch unit to activate the motor. The device should be disposed of at the end of the six week treatment.
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