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FDA 510(k)

Pelvic Floor Muscle Stimulator

K-Number: K230767 · 2023-09-21

Decision Date2023-09-21
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Pelvic Floor Muscle Stimulator is a medical device manufactured by Nanjing Vishee Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-09-21 under approval 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. It is manufactured by Nanjing Vishee Medical Technology Co., Ltd.. The 510(k) number is K230767.

When was Pelvic Floor Muscle Stimulator approved by the FDA?

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

What company makes Pelvic Floor Muscle Stimulator?

Pelvic Floor Muscle Stimulator is manufactured by Nanjing Vishee Medical Technology Co., Ltd..

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

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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.