Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow)
FDA 510(k) clearance K250419 · decided 2026-07-27
Clearance details
- K-number
- K250419
- Device name
- 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
- Decision
- Substantially Equivalent
- Date received
- 2025-02-13
- Decision date
- 2026-07-27
- Days to decision
- 529 days
- Clearance type
- Traditional
- Product code
- OSD
- Device class
- 2
- Regulation number
- 890.5670
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- North Kansas City, MO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AHIP INTERNAL TRIGGER POINT WAND MODEL: 1 (DEN100023) | National Center For Pelvic Pain Research Devices, | 2012-11-20 |
Recalls involving this device
No recalls on record reference this clearance.