Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

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

N.º K: K250419 · 2026-07-27

SolicitantePlus EV Holdings, Inc. D/B/A Intimate Rose
Fecha de decisión2026-07-27
Código de productoOSD
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

¿Cuál es el código de producto de la FDA para el Intimate Rose Pelvic Wand (Púrpura); Intimate Rose Bendable Pelvic Wand (Naranja); Intimate Rose Temperature Pelvic Wand (Amarillo)?

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

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

↑