动力轮椅（移动机器人）（M4，M4U）
K号: K242358 · 2025-04-03
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决定日期2025-04-03
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
Powered wheelchair (mobility robot) (M4, M4U) is the device name listed in this FDA 510(k) record. The listed applicant is Xsto Co., Ltd.. It received FDA 510(k) clearance on 2025-04-03 under 510(k) number K242358. 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 Powered wheelchair (mobility robot) (M4, M4U)?
Powered wheelchair (mobility robot) (M4, M4U) is a medical device that received FDA 510(k) clearance on 2025-04-03. The listed applicant is Xsto Co., Ltd.. The 510(k) number is K242358.
When did Powered wheelchair (mobility robot) (M4, M4U) receive FDA 510(k) clearance?
Powered wheelchair (mobility robot) (M4, M4U) received FDA 510(k) clearance on 2025-04-03, under 510(k) number K242358.
Who is the listed applicant for Powered wheelchair (mobility robot) (M4, M4U)?
The FDA 510(k) record lists Xsto Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Powered wheelchair (mobility robot) (M4, M4U)?
The FDA product code for Powered wheelchair (mobility robot) (M4, M4U) is ITI.
相关临床试验
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。
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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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