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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 a medical device manufactured by Shenzhen Med-Link Electronics Tech Co., Ltd.. It received FDA 510(k) clearance on 2021-09-17 under approval 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. It is manufactured by Shenzhen Med-Link Electronics Tech Co., Ltd.. The 510(k) number is K210441.

When was Incontinence Probe approved by the FDA?

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

What company makes Incontinence Probe?

Incontinence Probe is manufactured by Shenzhen Med-Link Electronics Tech Co., Ltd..

What is the FDA product code for Incontinence Probe?

The FDA product code for Incontinence Probe is KPI.

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Related Devices (Code: KPI)

K162010HPM-6000UBTL Industries, Inc. K161055Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15Fuji Dynamics , Ltd. K160773Yarlap IIInternational Trade Group, Inc. K161349Everyway Incontinence Stimulation SystemEveryway Medical Instrument Co., Ltd. K181497HPM-6000UFBTL Industries, Inc. K171430Incontinence Treatment Device, Model LT2061Shenzhen Dongdixin 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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