FDA.reportPublic FDA data

510(k) K142304

Device
Viberect Penile Vibratory Stimulation Device
Applicant
REFLEXONIC, LLC
510(k) number
K142304
Product code
KXQ  
Decision
Substantially Equivalent (SESE)
Decision date
2014-10-03
Date received
2014-08-18
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
Kambiz Tajkarimi
Address
915 Toll House Ave., Suite 205 Frederick MD US 21701 21701

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
K110566VIBERECT PENILE VIBRATORY STIMULATION DEVICEReflexonic, LLC2011-06-24
K010096MULTI CARE THERAPEUTIC VIBRATORMulticept A/S2001-03-05
K955589FERTICARE PERSONAL THERAPEUTIC VIBRATORMulticept, Aps.1996-04-11

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases