FDA 510(k)

Perfect PFE

K-Number: K191312 · 2019-11-01

Decision Date2019-11-01

Product CodeKPI

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Perfect PFE is a medical device manufactured by Tenscare, Ltd.. It received FDA 510(k) clearance on 2019-11-01 under approval number K191312. 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 Perfect PFE?

Perfect PFE is a medical device that received FDA 510(k) clearance on 2019-11-01. It is manufactured by Tenscare, Ltd.. The 510(k) number is K191312.

When was Perfect PFE approved by the FDA?

Perfect PFE received FDA 510(k) clearance on 2019-11-01, under approval number K191312.

What company makes Perfect PFE?

Perfect PFE is manufactured by Tenscare, Ltd..

What is the FDA product code for Perfect PFE?

The FDA product code for Perfect PFE is KPI.

Other Devices by Tenscare, Ltd.

K200694Perfect EMS K230926Ova+ (K-OVAP-USA) K230983Unicare (K-UNICARE-USA) K231053Unicare (K-UNICARE-USA) K232441Unipro (K-UNIPRO-US)

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

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