輪椅
K 號：K182471 · 2019-07-10
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器材摘要
Scooter is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Kepler Vehicle Industry Co. , Ltd.. It received FDA 510(k) clearance on 2019-07-10 under 510(k) number K182471. 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 Scooter?
Scooter is a medical device that received FDA 510(k) clearance on 2019-07-10. The listed applicant is Tianjin Kepler Vehicle Industry Co. , Ltd.. The 510(k) number is K182471.
When did Scooter receive FDA 510(k) clearance?
Scooter received FDA 510(k) clearance on 2019-07-10, under 510(k) number K182471.
Who is the listed applicant for Scooter?
The FDA 510(k) record lists Tianjin Kepler Vehicle Industry Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Scooter?
The FDA product code for Scooter is INI.
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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。
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官方來源
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