FDA 510(k)

C.T.M 行動輪椅

K 號：K181344 · 2018-12-14

決定日期2018-12-14

產品代碼INI

諮詢委員會PM

決定相當於

器材摘要

C.T.M Mobility Scooter is the device name listed in this FDA 510(k) record. The listed applicant is Chien TI Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2018-12-14 under 510(k) number K181344. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the C.T.M Mobility Scooter?

C.T.M Mobility Scooter is a medical device that received FDA 510(k) clearance on 2018-12-14. The listed applicant is Chien TI Enterprise Co., Ltd.. The 510(k) number is K181344.

When did C.T.M Mobility Scooter receive FDA 510(k) clearance?

C.T.M Mobility Scooter received FDA 510(k) clearance on 2018-12-14, under 510(k) number K181344.

Who is the listed applicant for C.T.M Mobility Scooter?

The FDA 510(k) record lists Chien TI Enterprise Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C.T.M Mobility Scooter?

The FDA product code for C.T.M Mobility Scooter is INI.

其他以 Chien TI Enterprise 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。

K192885C.T.M. 行動輪椅 HS-268 K162952C.T.M. 行動輪椅

相關器械（代碼：INI）

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。

K261078電動滑板車（FNS01,FNS03）Anhui Jbh Medical Apparatus Co., Ltd.K261859電動滑板車（FDB08、FDB08A、FDB12）Anhui JBH Medical Apparatus Co., Ltd.K260176行動輪椅（W3483、W3483A）Zhejiang Innuovo Rehabilitation Devices Co.,Ltd K260094行動輪椅（W3465，W3902（S50碳鋼））Zhejiang Innuovo Rehabilitation Devices Co.,Ltd K261232IERO行動輪椅（IERO-01）Jochu Technology Co., Ltd.K261163行動輪椅（R200）Yongkang Ruihe Metal Product Co., Ltd.

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。