JWG-1
K号: K252101 · 2026-03-19
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决定日期2026-03-19
产品代码ITI
咨询委员会PM
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决定实质等同
器械摘要
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.
常见问题
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.
列明Yamaha Motor Co., Ltd.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：ITI）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K262582电动轮椅（GP100）Suzhou Green Pine Medical Co., Ltd.K262054电动轮椅Yongkang Joymax Medical Technology Co., Ltd.K260053电动轮椅（OS-R-M01I）Beijing OrionStar Technology Co., Ltd.K260229电动轮椅（HC819N，HC830N，HC831N）Yongkang Hengyi Vehicle Co., Ltd.K261354电动轮椅（D03）Foshan Sowell Medical Technology Co., Ltd.K261149电动轮椅（DY611A-2，DY612A-1）Zhejiang Lumbre Electric Appliance Co., Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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