K-number	K242358
Device name	Powered wheelchair (mobility robot) (M4, M4U)
Applicant	Xsto Co., Ltd.
Product code	ITI
Device class	Class II
Decision date	Apr 3, 2025
Decision	Substantially Equivalent
Regulation	890.3860

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Powered wheelchair (mobility robot) model M4 and M4U is a motor-driven transportation vehicle designed to provide mobility to disabled or elderly persons who are limited to a seated position. It enables independent movement for users with mobility limitations.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

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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Powered wheelchair (mobility robot) (M4, M4U)

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