K-number	K243970
Device name	Portable Wheelchair
Applicant	Intradin (Shanghai) Machinery Co., Ltd.
Product code	ITI
Device class	Class II
Decision date	Mar 7, 2025
Decision	Substantially Equivalent
Regulation	890.3860

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Portable Wheelchair is a motor-driven device designed for indoor and outdoor mobility assistance. It is intended for disabled or elderly persons who are limited to a seated position and require motorized transportation.

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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Portable Wheelchair

Everything you need for a 510(k) submission. Nothing you don't.