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510(k) Data Aggregation
K Number
K142304Device Name
Viberect Penile Vibratory Stimulation Device
Manufacturer
Date Cleared
2014-10-03
(46 days)
Product Code
Regulation Number
884.5960Why did this record match?
Applicant Name (Manufacturer) :
REFLEXONIC, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Viberect® Penile Vibratory Stimulation Device is a hand held medical device to provoke erections for men who experience erectile dysfunction.
Device Description
The Viberect® device is a hand held medical device intended for use by the person at home for the purpose of stimulating the nerves of the penis for the purpose of activating several nerve reflexes which are responsible for initiation of penile erection and rigidity. This device is unique in that it has two gentle vibrating motors that allow simultaneous vibratory stimulation of both the upper and lower surfaces of the penis. As each side of the male penis is supplied by different nerves, simultaneous stimulation of the upper and lower surfaces increases sexual response.
The device is held by one hand easily, like holding a hair straightener. The penis is placed between the vibrating 'soft pads'. As pressure is increased to the device, it is automatically activated. The device can be deactivated by releasing the hand pressure which immediately shuts off the vibrating 'soft pads'. The touch pad on the Viberect provides further control by the user whereby the user can increase and decrease the frequency of vibration according to comfort and response. Finally, there are individual modes for the vibratory movement of the upper housing only, lower housing only, and both. The device is powered by rechargeable batteries. Vibratory stimulation for approximately 3-10 minutes is recommended.
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K Number
K110566Device Name
VIBERECT PENILE VIBRATORY STIMULATION DEVICE
Manufacturer
Date Cleared
2011-06-24
(116 days)
Regulation Number
884.5960Why did this record match?
Applicant Name (Manufacturer) :
REFLEXONIC, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Viberect™ Penile Vibratory Stimulation Device is a hand held medical device indicated to provoke erections for men who experience erectile dysfunction and to provoke ejaculation for spinal cord injured men.
Device Description
The Viberect™ Penile Vibratory Stimulation Device is a hand held medical device intended for use by the person at home for the purpose of stimulating the nerves of the penis, as a form of sexual aid, or for the purpose of activating several nerve reflexes that men are born with which are responsible for initiation of penile erection and rigidity. This device is unique in that it has two gentle vibrating motors that allow simultaneous vibratory stimulation of both the upper and lower surfaces of the penis. As each side of the male penis is supplied by different nerves, simultaneous stimulation of the upper and lower surfaces increases sexual response.
The device is held by one hand easily, like holding a hair straightener. The penis is placed between the vibrating gel pads, made up of polyurethane soft pads. As pressure is increased to the device, it is automatically activated. The device can be deactivated by releasing the hand pressure which immediately shuts off the vibrating heads. Therefore, the user activates and deactivates the device by hand pressure alone (i.e., no switches need to be pushed). Vibratory stimulation for approximately 7-10 minutes is recommended. The touch pad provides further control by the user whereby the user can increase and decrease the frequency of vibration according to comfort and response. Finally, there are individual modes for the vibratory movement of the upper housing only, lower housing only, and both. The device is powered by rechargeable batteries.
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