Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow)

K-Number: K250419 · 2026-07-27

ApplicantPlus EV Holdings, Inc. D/B/A Intimate Rose
Decision Date2026-07-27
Product CodeOSD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow) is the device name listed in this FDA 510(k) record. The listed applicant is Plus EV Holdings, Inc. D/B/A Intimate Rose. It received FDA 510(k) clearance on 2026-07-27 under 510(k) number K250419. The device is classified under product code OSD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow)?

Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow) is a medical device that received FDA 510(k) clearance on 2026-07-27. The listed applicant is Plus EV Holdings, Inc. D/B/A Intimate Rose. The 510(k) number is K250419.

When did Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow) receive FDA 510(k) clearance?

Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow) received FDA 510(k) clearance on 2026-07-27, under 510(k) number K250419.

Who is the listed applicant for Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow)?

The FDA 510(k) record lists Plus EV Holdings, Inc. D/B/A Intimate Rose as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow)?

The FDA product code for Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow) is OSD.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑