eFOLDi 导航电动轮椅（STPC-A）
K号: K243110 · 2025-05-08
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决定日期2025-05-08
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
eFOLDi Navigator Powerchair (STPC-A) is the device name listed in this FDA 510(k) record. The listed applicant is Suntech UK , Ltd.. It received FDA 510(k) clearance on 2025-05-08 under 510(k) number K243110. 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 eFOLDi Navigator Powerchair (STPC-A)?
eFOLDi Navigator Powerchair (STPC-A) is a medical device that received FDA 510(k) clearance on 2025-05-08. The listed applicant is Suntech UK , Ltd.. The 510(k) number is K243110.
When did eFOLDi Navigator Powerchair (STPC-A) receive FDA 510(k) clearance?
eFOLDi Navigator Powerchair (STPC-A) received FDA 510(k) clearance on 2025-05-08, under 510(k) number K243110.
Who is the listed applicant for eFOLDi Navigator Powerchair (STPC-A)?
The FDA 510(k) record lists Suntech UK , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for eFOLDi Navigator Powerchair (STPC-A)?
The FDA product code for eFOLDi Navigator Powerchair (STPC-A) is ITI.
相关临床试验
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列明Suntech UK , 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。
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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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