FDA 510(k)

生物回饋神經與肌肉刺激器

K 號：K220161 · 2022-07-20

決定日期2022-07-20

產品代碼KPI

諮詢委員會GU

決定相當於

器材摘要

Biofeedback Nerve and Muscle Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Konmed Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-20 under 510(k) number K220161. 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 Biofeedback Nerve and Muscle Stimulator?

Biofeedback Nerve and Muscle Stimulator is a medical device that received FDA 510(k) clearance on 2022-07-20. The listed applicant is Shenzhen Konmed Technology Co., Ltd.. The 510(k) number is K220161.

When did Biofeedback Nerve and Muscle Stimulator receive FDA 510(k) clearance?

Biofeedback Nerve and Muscle Stimulator received FDA 510(k) clearance on 2022-07-20, under 510(k) number K220161.

Who is the listed applicant for Biofeedback Nerve and Muscle Stimulator?

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

What is the FDA product code for Biofeedback Nerve and Muscle Stimulator?

The FDA product code for Biofeedback Nerve and Muscle Stimulator is KPI.

其他以 Shenzhen Konmed 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。

K260178骨盆肌肉訓練器（KM510、KM516B）K233576康美不斷電刺激電極（陰道探針：KM-503、KM-504、KM-505、KM-506、KM-507、KM-5013；直腸探針：KM-502、KM-5018）K202648生物回饋神經與肌肉刺激器 K163288Pelvifine 骨盆肌肉訓練器 K171722電極帶釋扣 / 電極帶尾針 K171721電極具有銀導電性

查看所有 7 項裝置 →

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。