FDA 510(k)

ATTO 移动轮椅

K 號：K160909 · 2016-10-04

決定日期2016-10-04

產品代碼INI

諮詢委員會PM

決定相當於

器材摘要

ATTO Mobility Scooter is the device name listed in this FDA 510(k) record. The listed applicant is Moving Life, Ltd.. It received FDA 510(k) clearance on 2016-10-04 under 510(k) number K160909. 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 ATTO Mobility Scooter?

ATTO Mobility Scooter is a medical device that received FDA 510(k) clearance on 2016-10-04. The listed applicant is Moving Life, Ltd.. The 510(k) number is K160909.

When did ATTO Mobility Scooter receive FDA 510(k) clearance?

ATTO Mobility Scooter received FDA 510(k) clearance on 2016-10-04, under 510(k) number K160909.

Who is the listed applicant for ATTO Mobility Scooter?

The FDA 510(k) record lists Moving Life, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATTO Mobility Scooter?

The FDA product code for ATTO Mobility Scooter is INI.

其他以 Moving Life, 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。

K222703ATTO 移动轮椅 (ATTO)；ATTO 移动轮椅 (ATTO SPORT)；ATTO 移动轮椅 (ATTO SPORT MAX)

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

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