FDA 510(k)

Levina 骨盆底肌肉刺激器 (RS-48)

K 號：K241862 · 2025-03-27

決定日期2025-03-27

產品代碼KPI

諮詢委員會GU

決定相當於

器材摘要

Levina Pelvic Floor Muscle Stimulator (RS-48) is the device name listed in this FDA 510(k) record. The listed applicant is Zmi Electronics , Ltd.. It received FDA 510(k) clearance on 2025-03-27 under 510(k) number K241862. 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 Levina Pelvic Floor Muscle Stimulator (RS-48)?

Levina Pelvic Floor Muscle Stimulator (RS-48) is a medical device that received FDA 510(k) clearance on 2025-03-27. The listed applicant is Zmi Electronics , Ltd.. The 510(k) number is K241862.

When did Levina Pelvic Floor Muscle Stimulator (RS-48) receive FDA 510(k) clearance?

Levina Pelvic Floor Muscle Stimulator (RS-48) received FDA 510(k) clearance on 2025-03-27, under 510(k) number K241862.

Who is the listed applicant for Levina Pelvic Floor Muscle Stimulator (RS-48)?

The FDA 510(k) record lists Zmi Electronics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Levina Pelvic Floor Muscle Stimulator (RS-48)?

The FDA product code for Levina Pelvic Floor Muscle Stimulator (RS-48) is KPI.

其他以 Zmi Electronics , 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。

K231166Levina，Levina失禁刺激電極（無菌），骨盆底肌肉探針電極 K180865ZMI自粘電極

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。

K262353BTL-299-FBTL Industries, Inc.K260178骨盆肌肉訓練器（KM510、KM516B）Shenzhen Konmed Technology Co., Ltd.K252601骨盆肌肉訓練器（PC22A）；骨盆肌肉訓練器（PC22A-L）；骨盆肌肉訓練器（PC22E）；骨盆肌肉訓練器（PC22E-L）Hunan Accurate Bio-Medical Technology Co., Ltd.K252552骨盆底復健治療設備（PD2301/PD2302/PD2303）Shenzhen Changkun Technology Co., Ltd.K252831骨盆底治療裝置 (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)Dolanvy (Suzhou) Medical Technology Co., Ltd.K252334PELVIPOWER 盆腔功能磁刺激器（PELVIPOWER 盆腔FMS）（033-0-1100-02）Pontemedag

官方來源

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