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FDA 510(k)

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

Número K: K250419 · 2026-07-27

RequerentePlus EV Holdings, Inc. D/B/A Intimate Rose
Data da decisão2026-07-27
Código do produtoOSD
Comité consultivoPM
DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

Qual é o código de produto da FDA para Intimate Rose Pelvic Wand (Rosa); Intimate Rose Bendable Pelvic Wand (Laranja); Intimate Rose Temperature Pelvic Wand (Amarelo)?

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

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Fonte oficial

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