FDA 510(k)

Levina，Levina失禁刺激電極（無菌），骨盆底肌肉探針電極

K 號：K231166 · 2024-01-18

決定日期2024-01-18

產品代碼KPI

諮詢委員會GU

決定相當於

器材摘要

Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes 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 2024-01-18 under 510(k) number K231166. 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, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes?

Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes is a medical device that received FDA 510(k) clearance on 2024-01-18. The listed applicant is Zmi Electronics , Ltd.. The 510(k) number is K231166.

When did Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes receive FDA 510(k) clearance?

Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes received FDA 510(k) clearance on 2024-01-18, under 510(k) number K231166.

Who is the listed applicant for Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes?

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, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes?

The FDA product code for Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes 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。

K241862Levina 骨盆底肌肉刺激器 (RS-48)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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