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FDA 510(k)

Pelvifine Pelvic Muscle Trainer

K-Number: K163288 · 2018-01-18

ApplicantShenzhen Konmed Technology Co., Ltd.
Decision Date2018-01-18
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Pelvifine Pelvic Muscle Trainer is a medical device manufactured by Shenzhen Konmed Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-01-18 under approval number K163288. 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 Pelvifine Pelvic Muscle Trainer?

Pelvifine Pelvic Muscle Trainer is a medical device that received FDA 510(k) clearance on 2018-01-18. It is manufactured by Shenzhen Konmed Technology Co., Ltd.. The 510(k) number is K163288.

When was Pelvifine Pelvic Muscle Trainer approved by the FDA?

Pelvifine Pelvic Muscle Trainer received FDA 510(k) clearance on 2018-01-18, under approval number K163288.

What company makes Pelvifine Pelvic Muscle Trainer?

Pelvifine Pelvic Muscle Trainer is manufactured by Shenzhen Konmed Technology Co., Ltd..

What is the FDA product code for Pelvifine Pelvic Muscle Trainer?

The FDA product code for Pelvifine Pelvic Muscle Trainer is KPI.

Related Clinical Trials

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Other Devices by Shenzhen Konmed Technology Co., Ltd.

K171722Electrodes with snap / Electrodes with pigtail K171721Electrodes with silver conductive K202648Biofeedback Nerve and Muscle Stimulator K220161Biofeedback Nerve and Muscle Stimulator K233576Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)

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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