FDA 510(k)

骨盆底肌肉刺激器

K 號：K230767 · 2023-09-21

申請人Nanjing Vishee Medical Technology Co., Ltd.

決定日期2023-09-21

產品代碼KPI

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

其他以 Nanjing Vishee Medical Technology Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K222875動力肌肉刺激器（型號名稱：MagGraver F200）

相關器械（代碼：KPI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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