电动轮椅（Rollz Motion Electric 2M）
K号: K250819 · 2025-11-07
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决定日期2025-11-07
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
Electric Wheelchair (Rollz Motion Electric 2M) is the device name listed in this FDA 510(k) record. The listed applicant is Rollz International BV. It received FDA 510(k) clearance on 2025-11-07 under 510(k) number K250819. 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 Electric Wheelchair (Rollz Motion Electric 2M)?
Electric Wheelchair (Rollz Motion Electric 2M) is a medical device that received FDA 510(k) clearance on 2025-11-07. The listed applicant is Rollz International BV. The 510(k) number is K250819.
When did Electric Wheelchair (Rollz Motion Electric 2M) receive FDA 510(k) clearance?
Electric Wheelchair (Rollz Motion Electric 2M) received FDA 510(k) clearance on 2025-11-07, under 510(k) number K250819.
Who is the listed applicant for Electric Wheelchair (Rollz Motion Electric 2M)?
The FDA 510(k) record lists Rollz International BV as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Electric Wheelchair (Rollz Motion Electric 2M)?
The FDA product code for Electric Wheelchair (Rollz Motion Electric 2M) is ITI.
相关临床试验
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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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