FDA 510(k)

JWG-1

K 號：K252101 · 2026-03-19

決定日期2026-03-19

產品代碼ITI

諮詢委員會PM

決定相當於

器材摘要

JWG-1 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 2026-03-19 under 510(k) number K252101. 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 JWG-1?

JWG-1 is a medical device that received FDA 510(k) clearance on 2026-03-19. The listed applicant is Yamaha Motor Co., Ltd.. The 510(k) number is K252101.

When did JWG-1 receive FDA 510(k) clearance?

JWG-1 received FDA 510(k) clearance on 2026-03-19, under 510(k) number K252101.

Who is the listed applicant for JWG-1?

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 JWG-1?

The FDA product code for JWG-1 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。

K203806JWX-1 Plus (Navigo 16/Navigo 24)

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。

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官方來源

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