Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow)
K250419 is the FDA 510(k) clearance record for Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow), a class II device, cleared for Plus EV Holdings, Inc. D/B/A Intimate Rose on under FDA product code OSD (Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature). FDA's definition for product code OSD reads: "Rectal or vaginal use manual therapeutic massager device to massage irritable, sore trigger points (trps) in the pelvic floor musculature in order to reduce internal pelvic floor trigger point sensitivity". FDA records list one 510(k) clearance for Plus EV Holdings, Inc. D/B/A Intimate Rose. As of , FDA records show no recalls naming K250419.
Clearance record
- Decision date
- Received
- (529 days to decision)
- Product code
- OSD Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
- Regulation
- 21 CFR 890.5670
- Device class
- Class II
- Review panel
- Physical Medicine
- Applicant
- Plus EV Holdings, Inc. D/B/A Intimate Rose 1419 Murray St., North Kansas City MO
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code OSD
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 1 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
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