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

Q: What is the product code of K250419?

The FDA product code is OSD – Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, a Class II (moderate risk) device regulated under 21 CFR 890.5670.

FDA 510(k) K250419 · Plus EV Holdings, Inc. D/B/A Intimate Rose

Substantially Equivalent

510(k) numberK250419

Submission

Device name: Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow)
Applicant: Plus EV Holdings, Inc. D/B/A Intimate Rose
North Kansas City, MO, US
Received: February 13, 2025
Decision date: July 27, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OSD – Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
Device class: Class II (moderate risk)
Regulation: 21 CFR 890.5670
Specialty: Physical Medicine

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

Questions and answers

When was Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow) cleared by the FDA?

Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow) (K250419) received a 510(k) decision of Substantially Equivalent on July 27, 2026, 529 days after the submission was received.

What is the product code of K250419?

The FDA product code is OSD – Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, a Class II (moderate risk) device regulated under 21 CFR 890.5670.