K-numberK252835
Device nameElectric Scooter (S202572J, S2060, M2089, S2050)
ApplicantGuangdong Prestige Technology Co., Ltd.
Product codeINI
Device classClass II
Decision dateDec 23, 2025
DecisionSubstantially Equivalent
Regulation890.3800
AI Summary extracted from FDA summary PDF · never regenerated
Intended use

The Electric Scooter (models S202572J, S2060, M2089, S2050) is a motor-driven, battery-powered indoor mobility vehicle designed for disabled or elderly persons limited to a seated position. It features a foldable frame, electromagnetic braking system, rear-wheel drive, and a 25.2V lithium-ion battery with a maximum speed of 6 km/h and 15 km cruising range.

Technological characteristics

The subject device uses a 25.2V/10AH lithium battery and 24V/150W motor, compared to the predicate's 24V/10AH battery and 24V/120W motor. Frame materials vary by model: S202572J uses carbon fiber while S2060, M2089, and S2050 use aluminum alloy (matching predicate). Tire sizes differ slightly (7-8 inches vs. 6-7 inches), and the device is lighter (13.3–18.2 kg vs. 24–24.7 kg) with improved portability.

Test standards cited

ISO 7176 series (static stability, dynamic stability, braking, range, dimensions, speed, strength, climatic testing, obstacle climbing, control systems, labeling); IEC 60601-1-2:2020 and IEEE ANSI C63.18-2014 for electromagnetic compatibility; ISO 16840 for resistance to ignition; IEC 62133-2 for battery safety.

Substantial equivalence argument

The subject device is substantially equivalent to predicate K190737 because both are motorized three-wheeled vehicles with the same classification, product code, and intended use for disabled/elderly mobility. Minor differences in battery voltage, motor power, frame materials, and tire sizes do not raise safety or effectiveness concerns because all variants comply with ISO 7176 series standards and demonstrate equivalent durability and performance.

Extracted by AI from the official FDA summary PDF →
Source

View the full FDA submission: accessdata.fda.gov

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