OSD
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5670
- Medical specialty
- Physical Medicine
- FDA definition
- 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
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow) (K250419) | Plus EV Holdings, Inc. D/B/A Intimate Rose | 2026-07-27 |
| AHIP INTERNAL TRIGGER POINT WAND MODEL: 1 (DEN100023) | National Center For Pelvic Pain Research Devices, | 2012-11-20 |
Track OSD automatically
Every clearance here is in the API, with alerts when new ones post.