K-number	K253952
Device name	Power Wheelchair (OS-R-M01S)
Applicant	Beijing OrionStar Technology Co., Ltd.
Product code	ITI
Device class	Class II
Decision date	Apr 7, 2026
Decision	Substantially Equivalent
Regulation	890.3860

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Power Wheelchair (OS-R-M01S) is a powered mobility device intended to provide both indoor and outdoor mobility for persons with mobility impairment who are capable of operating a powered wheelchair. It is marketed for over-the-counter use.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Power Wheelchair (OS-R-M01S)

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