OSD — Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature Class II
FDA product code OSD covers "Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature", a Class II medical device regulated under 21 CFR 890.5670. Submissions are reviewed by the Physical Medicine panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OSD
- Device Class
- Class II
- Regulation Number
- 890.5670
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250419 | Plus Ev Holdings, Inc. D/B/A Intimate Rose | Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); | Jul 27, 2026 |
| DEN100023 | National Center For Pelvic Pain Research Devices | AHIP INTERNAL TRIGGER POINT WAND MODEL: 1 | Nov 20, 2012 |