K-number	K250027
Device name	Powered Mobility Scooter
Applicant	Intradin (Shanghai) Machinery Co., Ltd.
Product code	INI
Device class	Class II
Decision date	Feb 21, 2025
Decision	Substantially Equivalent
Regulation	890.3800

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Powered Mobility Scooter is a motorized three-wheeled vehicle intended for medical purposes to provide mobility to persons restricted to a sitting position. It is classified as a Class II device and marketed for over-the-counter use.

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 Mobility Scooter

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