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FDA 510(k)

Keffort (MC-100, MC-100A)

K-Number: K213133 · 2022-04-13

ApplicantOriental Inspiration Limited
Decision Date2022-04-13
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Keffort (MC-100, MC-100A) is the device name listed in this FDA 510(k) record. The listed applicant is Oriental Inspiration Limited. It received FDA 510(k) clearance on 2022-04-13 under 510(k) 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. The listed applicant is Oriental Inspiration Limited. The 510(k) number is K213133.

When did Keffort (MC-100, MC-100A) receive FDA 510(k) clearance?

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

Who is the listed applicant for Keffort (MC-100, MC-100A)?

The FDA 510(k) record lists Oriental Inspiration Limited as the applicant. This does not by itself establish the device manufacturer.

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 records listing Oriental Inspiration Limited as applicant

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.

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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

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

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