K-number	K243440
Device name	Electric Wheelchair (HC820N)
Applicant	Yongkang Hengyi Vehicle Co., Ltd.
Product code	ITI
Device class	Class II
Decision date	Dec 19, 2024
Decision	Substantially Equivalent
Regulation	890.3860

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Electric Wheelchair (HC820N) is a motor-driven indoor and outdoor transportation vehicle designed to provide mobility for disabled or elderly persons who are limited to a seated position. It enables users with mobility impairments to move independently in both indoor and outdoor environments.

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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Electric Wheelchair (HC820N)

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