510(k) K250419 ยท OSD Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
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 |
| Decision | Substantially Equivalent, Jul 27, 2026 |
| Received | Feb 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250419
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.