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FDA 510(k)

Everyway 緊急失禁刺激系統

K 號：K213116 · 2021-12-03

申請人Everyway Medical Instruments Co.,Ltd
決定日期2021-12-03
產品代碼KPI
諮詢委員會GU
決定相當於

器材摘要

Everyway Incontinence Stimulation System is the device name listed in this FDA 510(k) record. The listed applicant is Everyway Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2021-12-03 under 510(k) number K213116. 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 Everyway Incontinence Stimulation System?

Everyway Incontinence Stimulation System is a medical device that received FDA 510(k) clearance on 2021-12-03. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K213116.

When did Everyway Incontinence Stimulation System receive FDA 510(k) clearance?

Everyway Incontinence Stimulation System received FDA 510(k) clearance on 2021-12-03, under 510(k) number K213116.

Who is the listed applicant for Everyway Incontinence Stimulation System?

The FDA 510(k) record lists Everyway Medical Instruments Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Everyway Incontinence Stimulation System?

The FDA product code for Everyway Incontinence Stimulation System is KPI.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Everyway Medical Instruments 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。

K251856立式電池驅動OTC TENS/EMS組合刺激器，型號Z4K222488Everyway 適用OTC TENSK202849Everyway 適用OTC TENS，型號N103A/N302K202470Li電池驅動OTC TENS/EMS，型號EM-6000、EM-6100、EM-6200及EM-6300K202317Li電池驅動OTC TENS/EMS，型號EV-804、型號EV-805及型號EV-806K201335立式電池驅動OTC TENS/EMS組合刺激器

查看所有 13 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。

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官方來源

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