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FDA 510(k)

Pelvic Floor Muscle Stimulator

K-Number: K230767 · 2023-09-21

ApplicantNanjing Vishee Medical Technology Co., Ltd.
Decision Date2023-09-21
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Pelvic Floor Muscle Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Vishee Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-09-21 under 510(k) number K230767. 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 Pelvic Floor Muscle Stimulator?

Pelvic Floor Muscle Stimulator is a medical device that received FDA 510(k) clearance on 2023-09-21. The listed applicant is Nanjing Vishee Medical Technology Co., Ltd.. The 510(k) number is K230767.

When did Pelvic Floor Muscle Stimulator receive FDA 510(k) clearance?

Pelvic Floor Muscle Stimulator received FDA 510(k) clearance on 2023-09-21, under 510(k) number K230767.

Who is the listed applicant for Pelvic Floor Muscle Stimulator?

The FDA 510(k) record lists Nanjing Vishee Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pelvic Floor Muscle Stimulator?

The FDA product code for Pelvic Floor Muscle Stimulator is KPI.

Related Clinical Trials

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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Other records listing Nanjing Vishee Medical Technology Co., Ltd. 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.

K222875Powered Muscle Stimulator (Model name:MagGraver F200)

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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