510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K110566Substantially Equivalent

Viberect Penile Vibratory Stimulation Device

Reflexonic, LLC, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110566 is the FDA 510(k) clearance record for VIBERECT PENILE VIBRATORY STIMULATION DEVICE, a class II device, cleared for Reflexonic, LLC on under FDA product code KXQ (Vibrator For Therapeutic Use, Genital). FDA records list 2 510(k) clearances for Reflexonic, LLC, from to . As of , FDA records show no recalls naming K110566.

Clearance record

Decision date
Received
(116 days to decision)
Product code
KXQ Vibrator For Therapeutic Use, Genital
Regulation
21 CFR 884.5960
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Reflexonic, LLC 611 W. 5th St. Third Floor, Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KXQ

Trailing 12 months

FDA records hold no clearances under product code KXQ in the trailing twelve months.

FDA records show no clearances under product code KXQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KXQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260