Clearance Summary
Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow) received FDA 510(k) clearance under submission number K250419, sponsored by Plus EV Holdings, Inc. D/B/A Intimate Rose. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2026-07-27.
- Submission: K250419
- Applicant / Sponsor: Plus EV Holdings, Inc. D/B/A Intimate Rose
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5670
- Decision date: 2026-07-27
Classification & Regulation
This clearance is catalogued under FDA product code OSD and 21 CFR 890.5670, within the Physical Medicine review panel as a Class II device.