VIBERECT PENILE VIBRATORY STIMULATION DEVICE— 510(k) K110566

Name: FDA 510(k) clearance K110566
Creator: U.S. Food and Drug Administration
Published: 2011-06-24

Substantially Equivalent

Reflexonic, LLC

FDA 510(k) clearance K110566 for VIBERECT PENILE VIBRATORY STIMULATION DEVICE, Substantially Equivalent on 2011-06-24. Applicant: Reflexonic, LLC. Device class: 2.

Clearance details

Applicant: Reflexonic, LLC
Product code: Code KXQ
Device class: Class 2
Regulation: 21 CFR 884.5960
Advisory panel: Obstetrics/Gynecology
Date received: 2011-02-28
Decision date: 2011-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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