FDA 510(k)

JWX-1 Plus (Navigo 16/Navigo 24)

K 號：K203806 · 2021-05-21

決定日期2021-05-21

產品代碼ITI

諮詢委員會PM

決定相當於

器材摘要

JWX-1 Plus (Navigo 16/Navigo 24) is the device name listed in this FDA 510(k) record. The listed applicant is Yamaha Motor Co., Ltd.. It received FDA 510(k) clearance on 2021-05-21 under 510(k) number K203806. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the JWX-1 Plus (Navigo 16/Navigo 24)?

JWX-1 Plus (Navigo 16/Navigo 24) is a medical device that received FDA 510(k) clearance on 2021-05-21. The listed applicant is Yamaha Motor Co., Ltd.. The 510(k) number is K203806.

When did JWX-1 Plus (Navigo 16/Navigo 24) receive FDA 510(k) clearance?

JWX-1 Plus (Navigo 16/Navigo 24) received FDA 510(k) clearance on 2021-05-21, under 510(k) number K203806.

Who is the listed applicant for JWX-1 Plus (Navigo 16/Navigo 24)?

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

What is the FDA product code for JWX-1 Plus (Navigo 16/Navigo 24)?

The FDA product code for JWX-1 Plus (Navigo 16/Navigo 24) is ITI.

其他以 Yamaha Motor 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。

K252101JWG-1

相關器械（代碼：ITI）

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。

K262582電動輪椅（GP100）Suzhou Green Pine Medical Co., Ltd.K262054電動輪椅Yongkang Joymax Medical Technology Co., Ltd.K260053電動輪椅 (OS-R-M01I)Beijing OrionStar Technology Co., Ltd.K260229電動輪椅（HC819N、HC830N、HC831N）Yongkang Hengyi Vehicle Co., Ltd.K261354電動輪椅（D03）Foshan Sowell Medical Technology Co., Ltd.K261149電動輪椅（DY611A-2，DY612A-1）Zhejiang Lumbre Electric Appliance 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。