FDA 510(k)

索萊克斯電動滑板車（型號：S204311M、S204161、S204143）

K 號：K190737 · 2021-05-10

申請人Dongguan Prestige Sporting Goods Co., Ltd.

決定日期2021-05-10

產品代碼INI

諮詢委員會PM

決定相當於

器材摘要

Solax Electric Scooter (Models: S204311M, S204161, S204143) is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Prestige Sporting Goods Co., Ltd.. It received FDA 510(k) clearance on 2021-05-10 under 510(k) number K190737. 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 Solax Electric Scooter (Models: S204311M, S204161, S204143)?

Solax Electric Scooter (Models: S204311M, S204161, S204143) is a medical device that received FDA 510(k) clearance on 2021-05-10. The listed applicant is Dongguan Prestige Sporting Goods Co., Ltd.. The 510(k) number is K190737.

When did Solax Electric Scooter (Models: S204311M, S204161, S204143) receive FDA 510(k) clearance?

Solax Electric Scooter (Models: S204311M, S204161, S204143) received FDA 510(k) clearance on 2021-05-10, under 510(k) number K190737.

Who is the listed applicant for Solax Electric Scooter (Models: S204311M, S204161, S204143)?

The FDA 510(k) record lists Dongguan Prestige Sporting Goods Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Solax Electric Scooter (Models: S204311M, S204161, S204143)?

The FDA product code for Solax Electric Scooter (Models: S204311M, S204161, S204143) is INI.

其他以 Dongguan Prestige Sporting Goods 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。

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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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