FDA 510(k)

失禁治療設備，型號 LT2061

K 號：K171430 · 2018-03-15

申請人Shenzhen Dongdixin Technology Co., Ltd.

決定日期2018-03-15

產品代碼KPI

諮詢委員會GU

決定相當於

器材摘要

Incontinence Treatment Device, Model LT2061 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-03-15 under 510(k) number K171430. 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 Incontinence Treatment Device, Model LT2061?

Incontinence Treatment Device, Model LT2061 is a medical device that received FDA 510(k) clearance on 2018-03-15. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K171430.

When did Incontinence Treatment Device, Model LT2061 receive FDA 510(k) clearance?

Incontinence Treatment Device, Model LT2061 received FDA 510(k) clearance on 2018-03-15, under 510(k) number K171430.

Who is the listed applicant for Incontinence Treatment Device, Model LT2061?

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

What is the FDA product code for Incontinence Treatment Device, Model LT2061?

The FDA product code for Incontinence Treatment Device, Model LT2061 is KPI.

其他以 Shenzhen Dongdixin 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。

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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

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