FDA 510(k)

电动轮椅 (OS-R-M01S)

K号: K253952 · 2026-04-07

申请人Beijing OrionStar Technology Co., Ltd.

决定日期2026-04-07

产品代码ITI

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决定实质等同

器械摘要

Power Wheelchair (OS-R-M01S) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing OrionStar Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-07 under 510(k) number K253952. 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 Power Wheelchair (OS-R-M01S)?

Power Wheelchair (OS-R-M01S) is a medical device that received FDA 510(k) clearance on 2026-04-07. The listed applicant is Beijing OrionStar Technology Co., Ltd.. The 510(k) number is K253952.

When did Power Wheelchair (OS-R-M01S) receive FDA 510(k) clearance?

Power Wheelchair (OS-R-M01S) received FDA 510(k) clearance on 2026-04-07, under 510(k) number K253952.

Who is the listed applicant for Power Wheelchair (OS-R-M01S)?

FDA 510(k)记录将北京奥瑞星科技有限公司列为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Power Wheelchair (OS-R-M01S)?

The FDA product code for Power Wheelchair (OS-R-M01S) is ITI.

列明Beijing OrionStar Technology 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。

K260053电动轮椅（OS-R-M01I）

官方来源

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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。