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FDA 510(k)

Incontinence Probe

K-Number: K210441 · 2021-09-17

ApplicantShenzhen Med-Link Electronics Tech Co., Ltd.
Decision Date2021-09-17
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Incontinence Probe is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. It received FDA 510(k) clearance on 2021-09-17 under 510(k) number K210441. 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 Incontinence Probe?

Incontinence Probe is a medical device that received FDA 510(k) clearance on 2021-09-17. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. The 510(k) number is K210441.

When did Incontinence Probe receive FDA 510(k) clearance?

Incontinence Probe received FDA 510(k) clearance on 2021-09-17, under 510(k) number K210441.

Who is the listed applicant for Incontinence Probe?

The FDA 510(k) record lists Shenzhen Med-Link Electronics Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Incontinence Probe?

The FDA product code for Incontinence Probe is KPI.

Other records listing Shenzhen Med-Link Electronics Tech Co., Ltd. as applicant

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Related Devices (Code: KPI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.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)PontemedagK251760Well-Life Incontinence Stimulation System (WL-2405i(P))Well-Life Healthcare , 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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