K-number	K242714
Device name	Mobility Scooter (S-01); Mobility Scooter (S-02)
Applicant	Zhejiang Seedream Medical Equipment Co., Ltd.
Product code	INI
Device class	Class II
Decision date	Jan 23, 2025
Decision	Substantially Equivalent
Regulation	890.3800

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Mobility Scooter (S-01) and Mobility Scooter (S-02) are motor-driven, indoor and outdoor transportation vehicles designed to provide mobility to disabled or elderly persons who are limited to a seated position.

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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Mobility Scooter (S-01); Mobility Scooter (S-02)

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