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FDA 510(k)

Power Wheelchair (OS-R-M01S)

K-Number: K253952 · 2026-04-07

ApplicantBeijing OrionStar Technology Co., Ltd.
Decision Date2026-04-07
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Power Wheelchair (OS-R-M01S) is a medical device manufactured by Beijing OrionStar Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-07 under approval number K253952. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Beijing OrionStar Technology Co., Ltd.. The 510(k) number is K253952.

When was Power Wheelchair (OS-R-M01S) approved by the FDA?

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

What company makes Power Wheelchair (OS-R-M01S)?

Power Wheelchair (OS-R-M01S) is manufactured by Beijing OrionStar Technology Co., Ltd..

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

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

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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