K-number	K254012
Device name	Electric Wheelchair (E201)
Applicant	Nanjing CareMoving Rehabilitation Equipment Co.,Ltd
Product code	ITI
Device class	Class II
Decision date	Mar 24, 2026
Decision	Substantially Equivalent
Regulation	890.3860

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Electric Wheelchair (E201) is a battery-powered, four-wheeled motor-driven vehicle intended for indoor and outdoor transportation of disabled or elderly persons limited to a seated position. It features a foldable aluminum frame, Li-ion battery, brushless DC motors, joystick control, and an off-board charger with a maximum load capacity of 100 kg.

Technological characteristics

The subject device uses a single Li-ion 24V 6Ah battery compared to the predicate's dual 24V 13Ah pack; seat cushion material differs (PET vs. nylon); rear wheels are solid tires instead of pneumatic; and minor variations exist in overall dimensions, speed specifications, range, and obstacle-climbing ability. Core systems—motor type, driving mechanism, brake design, and control methodology—remain identical to the predicate.

Test standards cited

ISO 7176 series (parts 1–25) for wheelchair safety and performance; IEC 60601-1-2:2020 and IEC TR 60601-4-2:2016 for electromagnetic compatibility; ISO 10993 series (parts 1, 5, 10, 23) for biocompatibility; and IEC 62133-2:2017+A1:2021 for battery testing.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Electric Wheelchair (E201)

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