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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 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.

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. 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)?

The FDA 510(k) record lists Beijing OrionStar Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: ITI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance Co., Ltd.K261396Electric WheelchairNingbo Resshidi Medical Devices Co., Ltd.K261164Electric wheelchair (XW-LY007 )Yongkang Ruihe Metal Product Co., Ltd.K260937Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)Shanghai Waylong Intelligent Technology Co.,LtdK253812Power Wheelchair (W5915B, W5915C, W5915D)Zhejiang Innuovo Rehabilitation Devices Co.,LtdK260335Electric Wheelchair (S500-6)Zhongshan Sulenz Intelligent Technology Co., Ltd.

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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