FDA 510(k)

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

K号: K252552 · 2026-05-06

申请人Shenzhen Changkun Technology Co., Ltd.

决定日期2026-05-06

产品代码KPI

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决定实质等同

器械摘要

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.

常见问题

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.

列明Shenzhen Changkun Technology Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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相关器械（代码：KPI）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262353BTL-299-FBTL Industries, Inc.K260178盆底肌肉训练器（KM510，KM516B）Shenzhen Konmed Technology Co., Ltd.K252601盆底肌肉训练器（PC22A）；盆底肌肉训练器（PC22A-L）；盆底肌肉训练器（PC22E）；盆底肌肉训练器（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盆腔功能性磁刺激(PELVIPOWER盆腔FMS)(033-0-1100-02)Pontemedag K251760Well-Life 尿失禁刺激系统（WL-2405i(P)）Well-Life Healthcare , Ltd.

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