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THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / July 2026 / K250419

510(k) cleared

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

Plus EV Holdings, Inc. D/B/A Intimate Rose · Jul 27, 2026 · K250419

FDA cleared the Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow) from Plus EV Holdings, Inc. D/B/A Intimate Rose on Jul 27, 2026 under K250419, a traditional 510(k). The device falls under product code OSD, Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, regulated at 21 CFR 890.5670 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Feb 13, 2025. The decision came 529 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Plus EV Holdings, Inc. D/B/A Intimate Rose in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250419?

K250419 is the FDA 510(k) for Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow), submitted by Plus EV Holdings, Inc. D/B/A Intimate Rose. FDA's decision date was Jul 27, 2026, under product code OSD (Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature).

Who makes the Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow)?

Plus EV Holdings, Inc. D/B/A Intimate Rose, based in North Kansas City, MO, is the applicant of record for K250419.

How long did the K250419 review take?

FDA received the submission on Feb 13, 2025 and issued its decision on Jul 27, 2026, 529 days later.

← All decisions in July 2026

Sources