# K250419: Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow)

- Pathway: 510(k) (Traditional)
- Applicant: Plus EV Holdings, Inc. D/B/A Intimate Rose
- Decided: Jul 27, 2026 after 529 days
- Product code: OSD (Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature)
- Device class: 2
- Regulation: 21 CFR 890.5670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

Source page: https://510kreport.com/device/K250419
Methodology: https://510kreport.com/methodology