K-number	K242989
Device name	Electric Wheelchair (MODEL H)
Applicant	Nanjing E-Take Medical Apparatus Co., Ltd.
Product code	ITI
Device class	Class II
Decision date	Dec 31, 2024
Decision	Substantially Equivalent
Regulation	890.3860

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Electric Wheelchair (MODEL H) is a motor-driven vehicle intended for indoor and outdoor use 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.

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 (MODEL H)

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