Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow)— 510(k) K250419

Name: FDA 510(k) clearance K250419
Creator: U.S. Food and Drug Administration
Published: 2026-07-27

Substantially Equivalent

Plus EV Holdings, Inc. D/B/A Intimate Rose

FDA 510(k) clearance K250419 for Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow), Substantially Equivalent on 2026-07-27. Applicant: Plus EV Holdings, Inc. D/B/A Intimate Rose. Device class: 2.

Clearance details

Applicant: Plus EV Holdings, Inc. D/B/A Intimate Rose
Product code: Code OSD
Device class: Class 2
Regulation: 21 CFR 890.5670
Advisory panel: Physical Medicine
Date received: 2025-02-13
Decision date: 2026-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Kansas City, MO, US

Download summary PDF View on FDA.gov ↗

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