FDA 510(k)

Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)

N.º K: K252552 · 2026-05-06

SolicitanteShenzhen Changkun Technology Co., Ltd.

Fecha de decisión2026-05-06

Código de productoKPI

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Changkun Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-05-06 under 510(k) number K252552. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)?

Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) is a medical device that received FDA 510(k) clearance on 2026-05-06. The listed applicant is Shenzhen Changkun Technology Co., Ltd.. The 510(k) number is K252552.

When did Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) receive FDA 510(k) clearance?

Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) received FDA 510(k) clearance on 2026-05-06, under 510(k) number K252552.

Who is the listed applicant for Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)?

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

What is the FDA product code for Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)?

The FDA product code for Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) is KPI.

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Otros registros que enlistan a Shenzhen Changkun Technology Co., Ltd. como solicitante

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Dispositivos relacionados (Código: 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.K252831Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)Dolanvy (Suzhou) Medical 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.

Fuente oficial

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