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510(k) K110566

Device
VIBERECT PENILE VIBRATORY STIMULATION DEVICE
Applicant
REFLEXONIC, LLC
510(k) number
K110566
Product code
KXQ  
Decision
Substantially Equivalent (SESE)
Decision date
2011-06-24
Date received
2011-02-28
Regulation
884.5960
Classification name
Vibrator For Therapeutic Use, Genital
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CAROLINE TONTINI
Address
611 W. 5th St. Third Floor Austin TX US 78701 78701

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KXQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K142304Viberect Penile Vibratory Stimulation DeviceReflexonic, LLC2014-10-03
K010096MULTI CARE THERAPEUTIC VIBRATORMulticept A/S2001-03-05
K955589FERTICARE PERSONAL THERAPEUTIC VIBRATORMulticept, Aps.1996-04-11

Legacy Summary#

summary

FDA Review#

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