510(k) K250419
- Device
- Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow)
- Applicant
- Plus EV Holdings, Inc. D/B/A Intimate Rose
- 510(k) number
- K250419
- Product code
- OSD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-27
- Date received
- 2025-02-13
- Regulation
- 890.5670
- Classification name
- Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Aaron Wilt
- Address
- 1419 Murray St. North Kansas City MO US 64116 64116
FDA Registration Numbers#
- 3003895865
Source Documents#
Other 510(k) Records For Product Code OSD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN100023 | AHIP INTERNAL TRIGGER POINT WAND MODEL: 1 | National Center For Pelvic Pain Research Devices, | 2012-11-20 |