K-number	K253789
Device name	Electric wheelchair
Applicant	Zhejiang Yikang Medical Technology Co., Ltd.
Product code	ITI
Device class	Class II
Decision date	Feb 25, 2026
Decision	Substantially Equivalent
Regulation	890.3860

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

This is an electric wheelchair—a motor-driven transportation vehicle for indoor and outdoor use intended to provide mobility to disabled or elderly persons who are limited to a seated position. It is classified as a Class II powered wheelchair under 21 CFR 890.3860.

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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Electric wheelchair

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