510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN210012Unknown

vPatch

Virility Medical Ltd., Hod-Hasharon, IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN210012 is the FDA 510(k) clearance record for vPatch, a class II device, cleared for Virility Medical on under FDA product code QRC (Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation). FDA's definition for product code QRC reads: "A non-implanted electrical stimulation device for management of premature ejaculation is intended to be used in patients with premature ejaculation by delivery of electrical stimulation to the perineal muscles and nerves". FDA records list 3 510(k) clearances for Virility Medical, from to . As of , FDA records show no recalls naming DEN210012.

Clearance record

Decision date
Received
(238 days to decision)
Product code
QRC Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation
Regulation
21 CFR 876.5026
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Virility Medical 24 Hanagar St., Suite 106, Hod-Hasharon, IL
Third party review
No

Clearances, product code QRC

Trailing 12 months
1 clearance under product code QRC in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QRC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260