Medical Device
Manufacturing
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K250419Substantially Equivalent

Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow)

Plus EV Holdings, Inc. D/B/A Intimate Rose, North Kansas City MO / Traditional, Substantially Equivalent

K250419 is the FDA 510(k) clearance record for Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow), a class II device, cleared for Plus EV Holdings, Inc. D/B/A Intimate Rose on under FDA product code OSD (Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature). FDA's definition for product code OSD reads: "Rectal or vaginal use manual therapeutic massager device to massage irritable, sore trigger points (trps) in the pelvic floor musculature in order to reduce internal pelvic floor trigger point sensitivity". FDA records list one 510(k) clearance for Plus EV Holdings, Inc. D/B/A Intimate Rose. As of , FDA records show no recalls naming K250419.

Clearance record

Decision date
Received
(529 days to decision)
Product code
OSD Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
Regulation
21 CFR 890.5670
Device class
Class II
Review panel
Physical Medicine
Applicant
Plus EV Holdings, Inc. D/B/A Intimate Rose 1419 Murray St., North Kansas City MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OSD

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