510(k) K250419
K250419 is an FDA 510(k) premarket notification submitted by Plus EV Holdings, Inc. D/B/A Intimate Rose for the device "Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow)". The FDA issued a decision of Substantially Equivalent on Jul 27, 2026. The device falls under product code OSD (Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature), a Class II device regulated under 21 CFR 890.5670.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 27, 2026
- Date Received
- Feb 13, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
- Device Class
- Class II
- Regulation Number
- 890.5670
- Review Panel
- PM
- Submission Type
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