K250419
- 510(k) number
- K250419
- 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 MO · US
- Product code
- OSD — Massager, Therapeutic, To Internally Massage Trigger
- Decision date
- 2026-07-27
- Date received
- 2025-02-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
510(k) Summary (official FDA PDF): K250419.pdf
Official FDA record: K250419
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.