Intimate Rose Pelvic Wand (Purple) +2 more— 510(k) K250419
Substantially EquivalentPlus EV Holdings, Inc. D/B/A Intimate Rose
FDA 510(k) clearance K250419 for Intimate Rose Pelvic Wand (Purple) +2 more, Substantially Equivalent on 2026-07-27. Applicant: Plus EV Holdings, Inc. D/B/A Intimate Rose. Device class: 2.
Summary
Intimate Rose's clearance covers three pelvic wands: the Pelvic Wand (Purple), Bendable Pelvic Wand (Orange), and Temperature Pelvic Wand (Yellow). They're filed under OSD, therapeutic massagers to internally massage trigger points in the pelvic floor musculature.
Class II, 21 CFR 890.5670. The Obstetrics and Gynecology review panel handled it as a Traditional 510(k), though the record lists Physical Medicine as the classification panel.
The applicant, Plus EV Holdings (doing business as Intimate Rose), filed from North Kansas City, Missouri. Review took 529 calendar days (February 13, 2025 to July 27, 2026).
Clearance details
- Device name as filed
- 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
- Product code
- Product code OSD
- Device class
- Class 2
- Regulation
- 21 CFR 890.5670
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Kansas City, MO, US
Recent devices under product code OSD
view allData sourced from openFDA. This site is unofficial and independent of the FDA.