FDA 510(k)

Keffort (MC-100, MC-100A)

K-Number: K213133 · 2022-04-13

Decision Date2022-04-13

Product CodeKPI

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Keffort (MC-100, MC-100A) is a medical device manufactured by Oriental Inspiration Limited. It received FDA 510(k) clearance on 2022-04-13 under approval number K213133. 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 Keffort (MC-100, MC-100A)?

Keffort (MC-100, MC-100A) is a medical device that received FDA 510(k) clearance on 2022-04-13. It is manufactured by Oriental Inspiration Limited. The 510(k) number is K213133.

When was Keffort (MC-100, MC-100A) approved by the FDA?

Keffort (MC-100, MC-100A) received FDA 510(k) clearance on 2022-04-13, under approval number K213133.

What company makes Keffort (MC-100, MC-100A)?

Keffort (MC-100, MC-100A) is manufactured by Oriental Inspiration Limited.

What is the FDA product code for Keffort (MC-100, MC-100A)?

The FDA product code for Keffort (MC-100, MC-100A) is KPI.

Other Devices by Oriental Inspiration Limited

K170269Hee HR Mini K170260BC-001+ Acne Purifier K212285Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android) K233046Electrical Neuromuscular Stimulator, Cure Trio

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.