FDA 510(k)

Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)

Номер K: K252831 · 2026-04-28

ЗаявительDolanvy (Suzhou) Medical Technology Co., Ltd.

Дата решения2026-04-28

Код продуктаKPI

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927) is the device name listed in this FDA 510(k) record. The listed applicant is Dolanvy (Suzhou) Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-28 under 510(k) number K252831. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)?

Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927) is a medical device that received FDA 510(k) clearance on 2026-04-28. The listed applicant is Dolanvy (Suzhou) Medical Technology Co., Ltd.. The 510(k) number is K252831.

When did Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927) receive FDA 510(k) clearance?

Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927) received FDA 510(k) clearance on 2026-04-28, under 510(k) number K252831.

Who is the listed applicant for Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)?

The FDA 510(k) record lists Dolanvy (Suzhou) Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)?

The FDA product code for Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927) is KPI.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: KPI)

K262353BTL-299-FBTL Industries, Inc.K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd.K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)Hunan Accurate Bio-Medical Technology Co., Ltd.K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd.K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)Pontemedag K251760Well-Life Incontinence Stimulation System (WL-2405i(P))Well-Life Healthcare , Ltd.

Официальный источник

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