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FDA 510(k)

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

K-Number: K252552 · 2026-05-06

ApplicantShenzhen Changkun Technology Co., Ltd.
Decision Date2026-05-06
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Shenzhen Changkun Technology Co., Ltd.. The 510(k) number is K252552.

When was Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) approved by the FDA?

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

What company makes Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)?

Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) is manufactured by Shenzhen Changkun Technology Co., Ltd..

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.

Related Devices (Code: KPI)

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.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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