510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193364Substantially Equivalent

Intimate Rose Kegel Exercise System

Plus EV Holdings dba Intimate Rose, North Kansas City MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193364 is the FDA 510(k) clearance record for Intimate Rose Kegel Exercise System, a class II device, cleared for Plus EV Holdings Dba Intimate Rose on under FDA product code HIR (Perineometer). FDA records list 3 510(k) clearances for Plus EV Holdings Dba Intimate Rose, from to . As of , FDA records show no recalls naming K193364.

Clearance record

Decision date
Received
(264 days to decision)
Product code
HIR Perineometer
Regulation
21 CFR 884.1425
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Plus EV Holdings Dba Intimate Rose 1700 Iron St., North Kansas City MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HIR

Trailing 12 months
1 clearance under product code HIR 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 HIR, 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